FDA Warning Letters, 483s and Recalls: October 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 |
|---|---|---|---|
| Oct 31, 2019 | Bedfont Scientific, Ltd. | Devices | United Kingdom |
| Oct 31, 2019 | Biomedix Wai | Devices | United States |
| Oct 30, 2019 | Delori Industrial Co., Ltd. | Food/Cosmetics | China |
| Oct 30, 2019 | Dixon Fisheries Inc | Food/Cosmetics | United States |
| Oct 30, 2019 | FARMAKEIO OUTSOURCING LLC | Drugs | United States |
| Oct 29, 2019 | International Trading Pharm Lab Inc | Drugs | United States |
| Oct 29, 2019 | Professional Compounding Centers Of America | Drugs | United States |
| Oct 25, 2019 | Lea-Way Farms Inc. | Veterinary | United States |
| Oct 25, 2019 | Samchundang Pharm Co., Ltd. | Drugs | Korea (the Republic of) |
| Oct 25, 2019 | Stason Pharmaceuticals, Inc. | Drugs | United States |
| Oct 24, 2019 | GPC Medical Ltd. | Devices | India |
| Oct 23, 2019 | Neptunus Seafood B.V. | Food/Cosmetics | Netherlands |
| Oct 22, 2019 | Shriram Institute For Industrial Research | Drugs | India |
| Oct 21, 2019 | Brad D. Smith | Veterinary | United States |
| Oct 18, 2019 | Auro Pharmacies, Inc | Drugs | United States |
| Oct 18, 2019 | YAKSEONFOOD AGRICULTURAL Co.Ltd | Food/Cosmetics | Korea (the Republic of) |
| Oct 17, 2019 | A- Z Essential Pharmaceutical, Inc. | Food/Cosmetics | United States |
| Oct 17, 2019 | Gourmet Catering To Go, LLC | Food/Cosmetics | United States |
| Oct 17, 2019 | MANDELAY KFT | Devices | Hungary |
| Oct 16, 2019 | Carroll-Baccari Inc | Devices | United States |
| Oct 16, 2019 | Kennedy, Philip R. | Devices | United States |
| Oct 16, 2019 | Vetix Inc | Veterinary | United States |
| Oct 15, 2019 | GEN FOOD | Food/Cosmetics | Korea (the Republic of) |
| Oct 15, 2019 | Taejoon Pharmaceutical Co., Ltd. | Drugs | Korea (the Republic of) |
| Oct 11, 2019 | California IVF Fertility Center | Biologics | United States |
| Oct 11, 2019 | Milbar Laboratories, Inc. | Drugs | United States |
| Oct 10, 2019 | Global Medical Technology SL | Devices | Spain |
| Oct 10, 2019 | Happy Sprout Inc. | Food/Cosmetics | United States |
| Oct 10, 2019 | Sinzenard International Food Manufacturer, LLC | Food/Cosmetics | United States |
| Oct 10, 2019 | TruVision Health LLC | Food/Cosmetics | United States |
| Oct 8, 2019 | American CryoStem Corporation | Biologics | United States |
| Oct 8, 2019 | Honest Globe, Inc. | Drugs | United States |
| Oct 4, 2019 | American Contract Systems, Inc. | Devices | United States |
| Oct 1, 2019 | GREFI | Biologics | 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 820.100(a) | Lack of or inadequate procedures | 34 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 29 |
| 21 CFR 117.10 | Personnel | 22 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 22 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 18 |
| 21 CFR 117.35(c) | Pest control | 17 |
| FDCA 402(a)(4) | System for administration of drugs | 17 |
| 21 CFR 117.20(b) | Plant construction and design | 16 |
| 21 CFR 123.11(b) | Sanitation monitoring documentation | 16 |
| 21 CFR 123.6(c)(2) | Monitoring - none | 15 |
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 |
|---|---|---|---|
| Oct 30, 2019 | Wawona Frozen Foods Inc. | Food | FDA sampling found Hepatitis A in frozen raspberries. |
| Oct 30, 2019 | Wawona Frozen Foods Inc. | Food | FDA sampling found Hepatitis A in frozen raspberries. |
| Oct 29, 2019 | Massey Fish Company | Food | product tested positive for Listeria monocytogenes |
| Oct 29, 2019 | Massey Fish Company | Food | product tested positive for Listeria monocytogenes |
| Oct 28, 2019 | Smiths Medical ASD Inc. | Devices | There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and… |
| Oct 25, 2019 | ICU Medical Inc | Drugs | Presence of Particulate Matter. |
| Oct 25, 2019 | ICU Medical Inc | Drugs | Presence of Particulate Matter. |
| Oct 24, 2019 | Applied Medical Resources Corp | Devices | The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the… |
| Oct 24, 2019 | Applied Medical Resources Corp | Devices | The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the… |
| Oct 24, 2019 | Applied Medical Resources Corp | Devices | The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the… |
| Oct 24, 2019 | NORTH BAY PRODUCE INC. | Food | potential to be contaminated with Listeria monocytogenes |
| Oct 23, 2019 | Azuma Foods International Inc USA | Food | Direct Account randomly tested two products with presumptive positive results for Listeria monocytogenes. |
| Oct 23, 2019 | Azuma Foods International Inc USA | Food | Direct Account randomly tested two products with presumptive positive results for Listeria monocytogenes. |
| Oct 23, 2019 | Azuma Foods International Inc USA | Food | Direct Account randomly tested two products with presumptive positive results for Listeria monocytogenes. |
| Oct 23, 2019 | Azuma Foods International Inc USA | Food | Direct Account randomly tested two products with presumptive positive results for Listeria monocytogenes. |
| Oct 23, 2019 | DILIP CERAMICS DBA SHIVAM DISTRIBUT | Food | Product contains high levels of sulfites (114.65 mg/serving) |
| Oct 22, 2019 | Green Lumber Holdings, LLC | Drugs | Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the… |
| Oct 15, 2019 | Peekay International, Inc. | Food | Product contains undeclared sulfites |
| Oct 14, 2019 | Samurai, Inc. | Food | Undeclared allergen; fish |
| Oct 14, 2019 | Vita Food Products, Inc. | Food | Product tested positive for Listeria monocytogenes |
| Oct 11, 2019 | GE Healthcare, LLC | Devices | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear… |
| Oct 11, 2019 | GE Healthcare, LLC | Devices | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear… |
| Oct 11, 2019 | GE Healthcare, LLC | Devices | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear… |
| Oct 11, 2019 | GE Healthcare, LLC | Devices | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear… |
| Oct 11, 2019 | Medtronic Neuromodulation | Devices | There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear… |
| Oct 9, 2019 | Whole Foods Market | Food | Undeclared milk and eggs |
| Oct 8, 2019 | Fisherman's Pride Processor, Inc. Dba Neptune Foods | Food | Product mis-packaging; causing undeclared allergens (milk and soy lecithin). |
| Oct 3, 2019 | Ethicon Endo-Surgery Inc | Devices | The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed… |
| Oct 3, 2019 | Ethicon Endo-Surgery Inc | Devices | The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed… |
| Oct 3, 2019 | Ethicon Endo-Surgery Inc | Devices | The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed… |
| Oct 3, 2019 | Ethicon Endo-Surgery Inc | Devices | The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed… |
| Oct 3, 2019 | Grand Strand Sandwich Company,Inc. | Food | The firm was notified by their supplier of possible contamination of Listeria monocytogenes in the product. |
| Oct 3, 2019 | Grand Strand Sandwich Company,Inc. | Food | The firm was notified by their supplier of possible contamination of Listeria monocytogenes in the product. |
| Oct 1, 2019 | Coborn's, Inc | Food | Chicken Salad sandwiches have the potential to be contaminated with Listeria monocytogenes. |
| Oct 1, 2019 | Coborn's, Inc | Food | Chicken Salad sandwiches have the potential to be contaminated with Listeria monocytogenes. |
| Oct 1, 2019 | Coborn's, Inc | Food | Chicken Salad sandwiches have the potential to be contaminated with Listeria monocytogenes. |
| Oct 1, 2019 | E.A. Sween Co. | Food | Various sandwiches have the potential to be contaminated with Listeria monocytogenes. |
| Oct 1, 2019 | E.A. Sween Co. | Food | Various sandwiches have the potential to be contaminated with Listeria monocytogenes. |
| Oct 1, 2019 | E.A. Sween Co. | Food | Various sandwiches have the potential to be contaminated with Listeria monocytogenes. |
| Oct 1, 2019 | E.A. Sween Co. | Food | Various sandwiches have the potential to be contaminated with Listeria monocytogenes. |
| Oct 1, 2019 | E.A. Sween Co. | Food | Various sandwiches have the potential to be contaminated with Listeria monocytogenes. |
| Oct 1, 2019 | E.A. Sween Co. | Food | Various sandwiches have the potential to be contaminated with Listeria monocytogenes. |
| Oct 1, 2019 | E.A. Sween Co. | Food | Various sandwiches have the potential to be contaminated with Listeria monocytogenes. |
| Oct 1, 2019 | E.A. Sween Co. | Food | Various sandwiches have the potential to be contaminated with Listeria monocytogenes. |
| Oct 1, 2019 | E.A. Sween Co. | Food | Various sandwiches have the potential to be contaminated with Listeria monocytogenes. |
| Oct 1, 2019 | E.A. Sween Co. | Food | Various sandwiches have the potential to be contaminated with Listeria monocytogenes. |
| Oct 1, 2019 | E.A. Sween Co. | Food | Various sandwiches have the potential to be contaminated with Listeria monocytogenes. |
| Oct 1, 2019 | E.A. Sween Co. | Food | Various sandwiches have the potential to be contaminated with Listeria monocytogenes. |
| Oct 1, 2019 | E.A. Sween Co. | Food | Various sandwiches have the potential to be contaminated with Listeria monocytogenes. |
| Oct 1, 2019 | E.A. Sween Co. | Food | Various sandwiches have the potential to be contaminated with Listeria monocytogenes. |
| Oct 1, 2019 | Golden Dragon Fortune Cookies Co Inc | Food | undeclared milk |
| Oct 1, 2019 | Lipari Foods Operating Company, LLC. | Food | Products contain chicken which has been recalled by supplier because it may be contaminated with Listeria monocytogenes |
| Oct 1, 2019 | Lipari Foods Operating Company, LLC. | Food | Products contain chicken which has been recalled by supplier because it may be contaminated with Listeria monocytogenes |
| Oct 1, 2019 | Lipari Foods Operating Company, LLC. | Food | Products contain chicken which has been recalled by supplier because it may be contaminated with Listeria monocytogenes |
| Oct 1, 2019 | Rong Shing Trading NY Inc | Food | Product may contain undeclared allergens, specifically milk and eggs. |
| Oct 1, 2019 | Super World Trading Inc. | Food | Product contains undeclared sulfites. |
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