FDA Warning Letters, 483s and Recalls: February 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 |
|---|---|---|---|
| Feb 28, 2019 | Biocentric Lab LLC | Biologics | United States |
| Feb 28, 2019 | Hubbard Feeds, Inc., A Company Of Alltech | Veterinary | United States |
| Feb 28, 2019 | Ningbo Pulisi Daily Chemical Products Co., Ltd | Drugs | China |
| Feb 27, 2019 | Liquid Health Inc. | Food/Cosmetics | United States |
| Feb 27, 2019 | Matsun Nutrition Inc. | Food/Cosmetics | United States |
| Feb 25, 2019 | Virginia Center For Reproductive Medicine | Biologics | United States |
| Feb 22, 2019 | Fujian Dongshan Haikui Aquatic Products Group Co., Ltd. | Food/Cosmetics | China |
| Feb 22, 2019 | Gloria SA | Food/Cosmetics | Peru |
| Feb 22, 2019 | TSUKIJI MOTOHIKO CO., LTD. | Food/Cosmetics | Japan |
| Feb 21, 2019 | Kerry Inc. | Food/Cosmetics | United States |
| Feb 20, 2019 | Emcure Pharmaceuticals Limited | Drugs | India |
| Feb 19, 2019 | Golden Gate Soy Products, Inc. | Food/Cosmetics | United States |
| Feb 19, 2019 | Hill's Pet Nutrition Inc | Veterinary | United States |
| Feb 19, 2019 | Sunshine International Foods, Inc. | Food/Cosmetics | United States |
| Feb 15, 2019 | Belleview 402 LLC | Drugs | United States |
| Feb 15, 2019 | CEP Bio-Coat, LLC | Devices | United States |
| Feb 15, 2019 | D'Andrea Foods, Inc. | Food/Cosmetics | United States |
| Feb 15, 2019 | Deva Holding Anonim Sirketi - Cerkezkoy Subesi | Drugs | Turkey |
| Feb 15, 2019 | Polymer Technology Systems, Inc. | Devices | United States |
| Feb 15, 2019 | Prolifix Nutrition, LLC | Food/Cosmetics | United States |
| Feb 15, 2019 | Thomas Jefferson University Institutional Review Board | Biologics | United States |
| Feb 14, 2019 | Intrathecal Compounding Specialists, LLC | Drugs | United States |
| Feb 14, 2019 | James D. Hudson Livestock | Veterinary | United States |
| Feb 14, 2019 | Liquid Labs USA LLC | Tobacco | United States |
| Feb 14, 2019 | Todd & Patty Meech Dairy Farm | Veterinary | United States |
| Feb 14, 2019 | Velvet Ice Cream Company | Food/Cosmetics | United States |
| Feb 13, 2019 | Almark Foods, LLC | Food/Cosmetics | United States |
| Feb 13, 2019 | Limitless Trading LLC | Tobacco | United States |
| Feb 13, 2019 | Ng Zheng Inc | Food/Cosmetics | United States |
| Feb 12, 2019 | Chemco Corporation | Drugs | United States |
| Feb 11, 2019 | Let's Talk Health, Inc. | Food/Cosmetics | United States |
| Feb 11, 2019 | Nutrafill, LLC | Food/Cosmetics | United States |
| Feb 9, 2019 | Apitoria Pharma Private Limited | Drugs | India |
| Feb 8, 2019 | Best Nutrition Products, Inc. | Food/Cosmetics | United States |
| Feb 8, 2019 | Distribuidora La Jugosita, Inc. | Food/Cosmetics | United States |
| Feb 8, 2019 | Evig LLC | Food/Cosmetics | United States |
| Feb 8, 2019 | High Chemical Company, Div Of National Generic Distributors | Drugs | United States |
| Feb 8, 2019 | LNK International, Inc. | Drugs | United States |
| Feb 8, 2019 | Lupin Limited | Drugs | India |
| Feb 8, 2019 | Paisley Farm, LLC | Food/Cosmetics | United States |
| Feb 8, 2019 | Polimeros Y Servicios S.A. | Drugs | Costa Rica |
| Feb 8, 2019 | Premium Production, LLC | Food/Cosmetics | United States |
| Feb 7, 2019 | US Compounding Inc | Drugs | United States |
| Feb 6, 2019 | Beavers Dairy Farm | Veterinary | United States |
| Feb 6, 2019 | Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company | Drugs | United States |
| Feb 5, 2019 | Atlantic Bakery Ltd. | Food/Cosmetics | United States |
| Feb 5, 2019 | Ceba-Tek, Inc. | Food/Cosmetics | United States |
| Feb 5, 2019 | S&B Pharma LLC | Drugs | United States |
| Feb 5, 2019 | Strides Pharma Science Limited | Drugs | India |
| Feb 4, 2019 | University Fertility Laboratory, Inc. | Biologics | United States |
| Feb 2, 2019 | Apitoria Pharma Private Limited | Drugs | India |
| Feb 2, 2019 | Apitoria Pharma Private Limited | Drugs | India |
| Feb 1, 2019 | Iacofano's Group LLC | 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 123.6(b) | No HACCP plan | 29 |
| 21 CFR 1.502(a) | Develop FSVP | 26 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 25 |
| 21 CFR 123.11(b) | Sanitation monitoring documentation | 23 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 23 |
| 21 CFR 117.10 | Personnel | 17 |
| 21 CFR 117.20(b) | Plant construction and design | 16 |
| 21 CFR 117.130(a)(1) | Hazard Analysis - Identification of Hazard | 15 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 14 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 14 |
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 |
|---|---|---|---|
| Feb 28, 2019 | Becton Dickinson & Company | Devices | Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the… |
| Feb 27, 2019 | Brainlab AG | Devices | In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial… |
| Feb 26, 2019 | The CF Sauer Company | Food | Monarch Southern BBQ contains soy and wheat. The firm had labels that properly described the product as Monarch Southern BBQ, but did not… |
| Feb 25, 2019 | Schiff Foods Products | Food | Product recalled due to the finding of Salmonella. |
| Feb 25, 2019 | Utz Quality Food Inc | Food | Utz Quality Food, LLC is initiating a recall of Bachman Original Twist Pretzels,10 oz.Bag (flexible film) Net Wt.: 10 oz., UPC: 0 77817… |
| Feb 22, 2019 | Asia Food Distributor | Food | Product contains undeclared milk. |
| Feb 22, 2019 | Golean Detox US | Drugs | Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenolphthalein. Sibutramine is an… |
| Feb 21, 2019 | ICU Medical, Inc. | Devices | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the… |
| Feb 21, 2019 | ICU Medical, Inc. | Devices | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the… |
| Feb 21, 2019 | ICU Medical, Inc. | Devices | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the… |
| Feb 21, 2019 | ICU Medical, Inc. | Devices | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the… |
| Feb 21, 2019 | ICU Medical, Inc. | Devices | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the… |
| Feb 21, 2019 | ICU Medical, Inc. | Devices | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the… |
| Feb 21, 2019 | ICU Medical, Inc. | Devices | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the… |
| Feb 20, 2019 | B&G Foods North America, Inc | Food | Product may contain undeclared cashews. |
| Feb 20, 2019 | LEAN CULINARY SERVICES, LLC | Food | USDA product sample taken (chicken salad) tested positive for Listeria monocytogenes. |
| Feb 20, 2019 | LEAN CULINARY SERVICES, LLC | Food | USDA product sample taken (chicken salad) tested positive for Listeria monocytogenes. |
| Feb 20, 2019 | LEAN CULINARY SERVICES, LLC | Food | USDA product sample taken (chicken salad) tested positive for Listeria monocytogenes. |
| Feb 20, 2019 | LEAN CULINARY SERVICES, LLC | Food | USDA product sample taken (chicken salad) tested positive for Listeria monocytogenes. |
| Feb 13, 2019 | Soom Foods | Food | Soom Foods is recalling its 1oz Chocolate Sweet Tahini Halva Spread squeeze packs (Code: 67333D)because our contracted manufacturer, Xela… |
| Feb 13, 2019 | Todd Holiday Dba Sunstone Organics | Drugs | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. |
| Feb 13, 2019 | Todd Holiday Dba Sunstone Organics | Drugs | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. |
| Feb 13, 2019 | Todd Holiday Dba Sunstone Organics | Drugs | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. |
| Feb 13, 2019 | Todd Holiday Dba Sunstone Organics | Drugs | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. |
| Feb 12, 2019 | O-Two Medical Technologies, Inc. | Devices | There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper… |
| Feb 12, 2019 | O-Two Medical Technologies, Inc. | Devices | There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper… |
| Feb 12, 2019 | O-Two Medical Technologies, Inc. | Devices | There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper… |
| Feb 8, 2019 | Maquet Cardiovascular Us Sales, Llc | Devices | Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate… |
| Feb 7, 2019 | Kingston Pharma LLC | Food | Presence of an undissolved ingredient, citrus flavonoid. |
| Feb 4, 2019 | Frito-Lay, Inc. | Food | Potential to contain undeclared milk |
| Feb 1, 2019 | Cook Inc. | Devices | The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during… |
| Feb 1, 2019 | Mylan Institutional Inc | Drugs | Presence of Particulate Matter: particulate matter identified as copper salts |
| Feb 1, 2019 | Physio-Control Inc | Devices | Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is… |
| Feb 1, 2019 | Physio-Control Inc | Devices | Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is… |
| Feb 1, 2019 | Whole Foods Market | Food | Report of anaphylactic reaction reported following the consumption of mislabeled cookies - undeclared walnuts. |
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.