FDA Warning Letters, 483s and Recalls: March 2019
Warning letters
A warning letter is FDA's formal notice that a firm has significant violations. Company names link to the letter on fda.gov. Tobacco retailer letters are counted above but not listed.
No warning letters outside tobacco are recorded for this month yet.
OAI inspections
OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after the inspection. Facility names link to the facility's FDA record.
| Date | Facility | Product type | Country |
|---|---|---|---|
| Mar 29, 2019 | ITG-Medev, Inc. | Devices | United States |
| Mar 29, 2019 | Pharma-Natural Inc. | Drugs | United States |
| Mar 28, 2019 | S&S X-Ray Products, Inc. | Devices | United States |
| Mar 27, 2019 | Sportron International, Inc | Food/Cosmetics | United States |
| Mar 26, 2019 | Nestle Purina PetCare Company | Veterinary | United States |
| Mar 22, 2019 | Absonutrix, LLC | Food/Cosmetics | United States |
| Mar 22, 2019 | Bayer AG | Drugs | Germany |
| Mar 22, 2019 | CMC Enterprise Pharmacy | Drugs | United States |
| Mar 22, 2019 | Lohxa LLC | Drugs | United States |
| Mar 22, 2019 | NingBo Huize Commodity Co.,Ltd. | Drugs | China |
| Mar 22, 2019 | Yino, Inc. (Trading Company) | Drugs | China |
| Mar 21, 2019 | Guangzhou Health & Health Medical Equipment Co., Ltd. | Devices | China |
| Mar 21, 2019 | Hangzhou Badi Daily Use Chemical Company | Drugs | China |
| Mar 21, 2019 | Shanghai Co-Fun Biotech Corp., Ltd. | Drugs | China |
| Mar 21, 2019 | WCM Waste & Compliance Management Inc | Devices | United States |
| Mar 20, 2019 | Allandale Dairy | Veterinary | United States |
| Mar 20, 2019 | Michigan Food Sales Inc. | Food/Cosmetics | United States |
| Mar 20, 2019 | Plantafood Medical Gmbh | Food/Cosmetics | Germany |
| Mar 19, 2019 | Aquila Farms, LLC | Veterinary | United States |
| Mar 19, 2019 | International Hospital Products, Inc. | Devices | United States |
| Mar 19, 2019 | Sircle Laboratories, L.L.C. | Drugs | United States |
| Mar 19, 2019 | Torrent Pharmaceuticals Limited | Drugs | India |
| Mar 18, 2019 | Front Door Pharmacy, LLC | Drugs | United States |
| Mar 15, 2019 | Aparna Pharmaceuticals Private Limited | Drugs | India |
| Mar 15, 2019 | Elwood International, Inc. | Food/Cosmetics | United States |
| Mar 15, 2019 | Enprani Co., Ltd. | Drugs | Korea (the Republic of) |
| Mar 15, 2019 | H & A Walters Fulfillment Center LLC. | Food/Cosmetics | United States |
| Mar 15, 2019 | Pavlos Trifonidis S.A | Food/Cosmetics | Greece |
| Mar 14, 2019 | Eonsmoke, LLC | Tobacco | United States |
| Mar 14, 2019 | Pacific Medical Group, Inc. | Devices | United States |
| Mar 14, 2019 | QuVa Pharma, Inc. | Drugs | United States |
| Mar 13, 2019 | Advance Pierre Foods | Food/Cosmetics | United States |
| Mar 12, 2019 | Derrek Olson, LLC | Veterinary | United States |
| Mar 12, 2019 | Preservation Solutions, Inc. | Devices | United States |
| Mar 11, 2019 | Kwokcheng Enterprise, Inc. | Food/Cosmetics | United States |
| Mar 8, 2019 | Provimi North America, LLC | Veterinary | United States |
| Mar 8, 2019 | Saalt, LLC | Devices | United States |
| Mar 8, 2019 | Stemell Inc | Biologics | United States |
| Mar 8, 2019 | T&W LLC | Food/Cosmetics | United States |
| Mar 7, 2019 | Hello Life, Inc | Food/Cosmetics | United States |
| Mar 7, 2019 | Henan Kangdi Medical Devices Co. Ltd | Drugs | China |
| Mar 7, 2019 | JAV 9 FOODS INC | Food/Cosmetics | United States |
| Mar 7, 2019 | U.F.S. Industries, Inc. | Food/Cosmetics | United States |
| Mar 6, 2019 | Flying Food Group, LLC | Food/Cosmetics | United States |
| Mar 6, 2019 | Santa Fe Products, Inc. | Food/Cosmetics | United States |
| Mar 6, 2019 | Sweet Production Inc. | Food/Cosmetics | United States |
| Mar 4, 2019 | Wewoka Animal Hospital | Veterinary | United States |
| Mar 1, 2019 | ALK-Abello, Inc. | Drugs | United States |
| Mar 1, 2019 | Haw Par Healthcare Limited | Drugs | Singapore |
| Mar 1, 2019 | Vaccaro's Italian Pastry Shop, Inc. | Food/Cosmetics | United States |
Most-cited Form 483 sections
The CFR sections FDA investigators cited most often in inspections that ended this month.
| CFR section | Observation | Citations |
|---|---|---|
| 21 CFR 1.502(a) | Maintain, follow FSVP | 40 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 29 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 29 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 25 |
| 21 CFR 117.20(b) | Plant construction and design | 24 |
| 21 CFR 123.6(b) | No HACCP plan | 22 |
| 21 CFR 123.11(b) | Sanitation monitoring documentation | 20 |
| 21 CFR 117.10 | Personnel | 19 |
| 21 CFR 117.35(c) | Pest control | 18 |
| 21 CFR 117.130(a)(1) | Hazard Analysis - Identification of Hazard | 16 |
Class I recalls
Class I is FDA's most serious recall class: a reasonable chance the product causes serious health problems or death.
| Date | Firm | Product type | Reason |
|---|---|---|---|
| Mar 30, 2019 | LITTLE RED ROOSTER COMPANY | Food | Undeclared almonds |
| Mar 28, 2019 | Aurobindo Pharma USA Inc. | Drugs | Presence of Particulate Matter: One vial was found to contain a hair. |
| Mar 28, 2019 | Edwards Lifesciences, LLC | Devices | Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment. |
| Mar 28, 2019 | Edwards Lifesciences, LLC | Devices | Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment. |
| Mar 27, 2019 | Theo Chocolate Inc | Food | Theo Chocolate Sea Salt 70% Dark Chocolate Bar is recalled due to undeclared milk. |
| Mar 27, 2019 | Thomas Hammer Coffee Roasters, Inc. | Food | Blueberry Bread is recalled due to undeclared egg. |
| Mar 25, 2019 | Hamilton Medical AG | Devices | New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory… |
| Mar 21, 2019 | Allen's Blueberry Freezer, Inc. | Food | Product tested positive for E.coli O157:H7 STEC. |
| Mar 21, 2019 | Edwards Lifesciences, LLC | Devices | Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets. |
| Mar 18, 2019 | Almark Foods Inc | Food | FDA notified the firm of positive test results for Listeria monocytogenes found in the firm. |
| Mar 15, 2019 | GE Healthcare, LLC | Devices | The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the… |
| Mar 15, 2019 | GE Healthcare, LLC | Devices | The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
| Mar 15, 2019 | Medtronic Vascular | Devices | There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F… |
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