FDA Warning Letters, 483s and Recalls: July 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 |
|---|---|---|---|
| Jul 30, 2019 | Continental Manufacturing Chemist | Veterinary | United States |
| Jul 30, 2019 | Continental Manufacturing Chemist, Inc. | Veterinary | United States |
| Jul 30, 2019 | CPAPNEA Medical Supply | Devices | United States |
| Jul 26, 2019 | New Spirit Naturals Inc. | Food/Cosmetics | United States |
| Jul 26, 2019 | Poon Goor Soe Manufacture Sdn. Bhd. | Drugs | Malaysia |
| Jul 26, 2019 | Unity Fertility Center, LLC | Biologics | United States |
| Jul 25, 2019 | American Contract Systems | Devices | United States |
| Jul 25, 2019 | Mandell's Clinical Pharmacy | Drugs | United States |
| Jul 23, 2019 | Foodworks International LLC | Food/Cosmetics | United States |
| Jul 23, 2019 | Henrys Farm Inc. | Food/Cosmetics | United States |
| Jul 23, 2019 | Hiland Dairy Foods Company, LLC | Food/Cosmetics | United States |
| Jul 23, 2019 | US Specialty Formulations LLC | Drugs | United States |
| Jul 19, 2019 | S Bailey Enterprises, LLC | Food/Cosmetics | United States |
| Jul 18, 2019 | D.A.Y. Farm | Food/Cosmetics | United States |
| Jul 18, 2019 | Shertech Pharmacy- Piedmont | Drugs | United States |
| Jul 18, 2019 | Zhuhai Aofute Medical Technology Co., Ltd. | Drugs | China |
| Jul 17, 2019 | CF Dallas LLC | Food/Cosmetics | United States |
| Jul 17, 2019 | Cosmelab Co Ltd | Drugs | Korea (the Republic of) |
| Jul 16, 2019 | Cache Commodities Incorporated | Veterinary | United States |
| Jul 16, 2019 | Custom Milling Center Inc | Devices | United States |
| Jul 16, 2019 | Zhuhai United Laboratories Co. Ltd. | Drugs | China |
| Jul 15, 2019 | Al Global, Inc. | Food/Cosmetics | United States |
| Jul 12, 2019 | American Pure Whey | Food/Cosmetics | United States |
| Jul 12, 2019 | G2G Bar, Inc | Food/Cosmetics | United States |
| Jul 12, 2019 | Herbalgy Pharmaceutical Ltd. | Drugs | Hong Kong SAR |
| Jul 11, 2019 | California Cereal Products | Food/Cosmetics | United States |
| Jul 11, 2019 | MARUDAI MINAMI SHOKUHIN | Food/Cosmetics | Japan |
| Jul 11, 2019 | Shanghai Xodus Medical Company Limited | Devices | China |
| Jul 10, 2019 | Banjaras Inc | Food/Cosmetics | United States |
| Jul 9, 2019 | LIANYUNGANG AIKANG FOOD CO., LTD | Food/Cosmetics | China |
| Jul 8, 2019 | James R. Corbett, M.D. | Drugs | United States |
| Jul 5, 2019 | Huaian Zongheng Bio-Tech Co., Ltd | Drugs | China |
| Jul 5, 2019 | Symbiotec Pharmalab Limited | Drugs | India |
| Jul 3, 2019 | Kevin Klug | Veterinary | United States |
| Jul 3, 2019 | RePharm LLC | Drugs | United States |
| Jul 3, 2019 | U.S. Dairy Unlimited, LLC | Food/Cosmetics | United States |
| Jul 2, 2019 | Shertech Pharmacy | Drugs | United States |
| Jul 2, 2019 | Washington Homeopathic Products, Inc. | Drugs | 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 | 47 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 36 |
| 21 CFR 117.35(c) | Pest control | 26 |
| 21 CFR 123.6(b) | No HACCP plan | 21 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 20 |
| 21 CFR 117.10 | Personnel | 19 |
| 21 CFR 123.11(b) | Sanitation monitoring | 19 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 18 |
| 21 CFR 211.22(d) | Procedures not in writing, fully followed | 17 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 17 |
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 |
|---|---|---|---|
| Jul 30, 2019 | Ruleau Bros, Inc. | Food | Undeclared Anchovy, Egg, Soy |
| Jul 30, 2019 | Teleflex Medical | Devices | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the… |
| Jul 30, 2019 | Teleflex Medical | Devices | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the… |
| Jul 30, 2019 | Teleflex Medical | Devices | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the… |
| Jul 30, 2019 | Teleflex Medical | Devices | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the… |
| Jul 30, 2019 | Teleflex Medical | Devices | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the… |
| Jul 30, 2019 | Teleflex Medical | Devices | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the… |
| Jul 30, 2019 | Teleflex Medical | Devices | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the… |
| Jul 30, 2019 | Teleflex Medical | Devices | Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the… |
| Jul 27, 2019 | Harvest Sensations, LLC | Food | Fresh Basil tested positive for Salmonella |
| Jul 25, 2019 | Mountain Mel's Essential Goods LLC | Food | Herbal Tea product is recalled due to a potential contamination with Salmonella. |
| Jul 25, 2019 | Mountain Mel's Essential Goods LLC | Food | Herbal Tea product is recalled due to a potential contamination with Salmonella. |
| Jul 25, 2019 | Mountain Mel's Essential Goods LLC | Food | Herbal Tea product is recalled due to a potential contamination with Salmonella. |
| Jul 24, 2019 | Allergan PLC | Devices | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher… |
| Jul 24, 2019 | Allergan PLC | Devices | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher… |
| Jul 24, 2019 | Allergan PLC | Devices | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher… |
| Jul 24, 2019 | Allergan PLC | Devices | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher… |
| Jul 24, 2019 | Allergan PLC | Devices | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher… |
| Jul 24, 2019 | Allergan PLC | Devices | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher… |
| Jul 24, 2019 | Allergan PLC | Devices | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher… |
| Jul 24, 2019 | Allergan PLC | Devices | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher… |
| Jul 24, 2019 | Allergan PLC | Devices | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher… |
| Jul 24, 2019 | Allergan PLC | Devices | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher… |
| Jul 24, 2019 | Allergan PLC | Devices | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher… |
| Jul 24, 2019 | Allergan PLC | Devices | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher… |
| Jul 24, 2019 | Allergan PLC | Devices | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher… |
| Jul 24, 2019 | Allergan PLC | Devices | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher… |
| Jul 24, 2019 | Allergan PLC | Devices | The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher… |
| Jul 24, 2019 | CH Guenther & Sons, Inc | Food | Products contains an ingredient (cumin) potentially contaminated with Salmonella. |
| Jul 24, 2019 | CH Guenther & Sons, Inc | Food | Products contains an ingredient (cumin) potentially contaminated with Salmonella. |
| Jul 24, 2019 | Euphoria Fancy Food, Inc. | Food | NYS found elevated levels of undeclared Sulfites in Tainy Vostoka Assorted Dry Fruits - Apple. |
| Jul 19, 2019 | Elevation Foods | Food | Listeria monocytogenes was found in egg salad produced by the firm. In abundance of caution, firm is recalling all product produced on the… |
| Jul 19, 2019 | The Cookie Dough Cafe | Food | Undeclared peanuts |
| Jul 18, 2019 | Mountain Rose Inc. Dba Mountain Rose Herbs | Food | Fennel Whole Seed is recalled due to a potential for contamination with Salmonella. |
| Jul 16, 2019 | FRUNUT GLOBAL COMMODITIES LLC | Food | Product contains undeclared sulfites. |
| Jul 16, 2019 | The Crystal Spoon Corp. | Food | Product may be contaminated with E.coli |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
| Jul 15, 2019 | Pita Pal Foods LP | Food | Product has potential to be contaminated with Listeria monocytogenes |
Check one company
See one company's full record with the free FDA compliance check, or search warning letters and Form 483 citations by name.