FDA Warning Letters, 483s and Recalls: July 2020
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 31, 2020 | White Trading Corporation | Food/Cosmetics | United States |
| Jul 29, 2020 | Mexi-Land, Inc. | Food/Cosmetics | United States |
| Jul 23, 2020 | Fresh Express Incorporated | Food/Cosmetics | United States |
| Jul 16, 2020 | Chaca Mexican Imports LLC | Food/Cosmetics | United States |
| Jul 8, 2020 | Italfoods, Inc. | Food/Cosmetics | United States |
| Jul 7, 2020 | Handylee Enterprises (USA) Corp. | Food/Cosmetics | United States |
| Jul 2, 2020 | Campimex, Inc | Food/Cosmetics | United States |
| Jul 2, 2020 | Ida Foods 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 1.502(a) | Maintain, follow FSVP | 39 |
| 21 CFR 1.505(a)(2) | Evaluation - performance, risk | 9 |
| 21 CFR 1.505(b) | Supplier approval - document | 8 |
| 21 CFR 1.506(b) | Supplier verification - establish written procedures | 8 |
| 21 CFR 1.506(a)(1) | Unapproved supplier procedures - importer established | 6 |
| 21 CFR 1.506(d)(1)(i) | Verification activity frequency | 5 |
| 21 CFR 1.512(b)(2) | Develop FSVP | 5 |
| 21 CFR 1.504(a) | Hazard analysis written | 4 |
| 21 CFR 1.504(b)(1) | Hazard analysis biological, chemical, physical | 4 |
| 21 CFR 1.506(d)(2) | Onsite audit | 4 |
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 31, 2020 | Emerald Fruit & Produce Inc | Food | Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson… |
| Jul 31, 2020 | Emerald Fruit & Produce Inc | Food | Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson… |
| Jul 31, 2020 | Emerald Fruit & Produce Inc | Food | Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson… |
| Jul 31, 2020 | Emerald Fruit & Produce Inc | Food | Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson… |
| Jul 31, 2020 | Emerald Fruit & Produce Inc | Food | Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson… |
| Jul 31, 2020 | Emerald Fruit & Produce Inc | Food | Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson… |
| Jul 31, 2020 | Emerald Fruit & Produce Inc | Food | Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson… |
| Jul 31, 2020 | Emerald Fruit & Produce Inc | Food | Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson… |
| Jul 31, 2020 | Emerald Fruit & Produce Inc | Food | Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson… |
| Jul 31, 2020 | Emerald Fruit & Produce Inc | Food | Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson… |
| Jul 31, 2020 | Emerald Fruit & Produce Inc | Food | Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson… |
| Jul 31, 2020 | Emerald Fruit & Produce Inc | Food | Processed onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson… |
| Jul 31, 2020 | MicroPort Orthopedics Inc. | Devices | MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck… |
| Jul 31, 2020 | MicroPort Orthopedics Inc. | Devices | MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck… |
| Jul 29, 2020 | SCA Pharmaceuticals | Drugs | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually… |
| Jul 29, 2020 | SCA Pharmaceuticals | Drugs | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually… |
| Jul 29, 2020 | SCA Pharmaceuticals | Drugs | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually… |
| Jul 29, 2020 | SCA Pharmaceuticals | Drugs | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually… |
| Jul 29, 2020 | Smith Foods Inc. | Food | Undeclared cashews in the product. |
| Jul 29, 2020 | Smith Foods Inc. | Food | Undeclared cashews in the product. |
| Jul 29, 2020 | Smith Foods Inc. | Food | Undeclared cashews in the product. |
| Jul 27, 2020 | Broncolin, S.A. De C.V. | Drugs | Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and… |
| Jul 24, 2020 | Advanced Compounds International, Inc. | Food | Product contains undeclared milk allergen. |
| Jul 24, 2020 | Wellements LLC | Food | Product contains undeclared milk |
| Jul 24, 2020 | Wellements LLC | Food | Product contains undeclared milk |
| Jul 24, 2020 | Whole Foods Market | Food | Potential to contain undeclared eggs |
| Jul 23, 2020 | Real Clean Distribuciones SA De CV | Drugs | Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other… |
| Jul 23, 2020 | Upspring,Ltd | Food | May contain undeclared milk |
| Jul 23, 2020 | Whole Foods Market | Food | Potential to contain undeclared tree nuts (almond) |
| Jul 22, 2020 | Fresenius Kabi USA, LLC | Drugs | Cross Contamination with other products: trace amounts of lidocaine |
| Jul 21, 2020 | Ferring Pharmaceuticals Inc | Drugs | Superpotent Drug |
| Jul 21, 2020 | Ferring Pharmaceuticals Inc | Drugs | Superpotent Drug |
| Jul 21, 2020 | Ferring Pharmaceuticals Inc | Drugs | Superpotent Drug |
| Jul 20, 2020 | Liq-E S.A. De C.V. | Drugs | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content |
| Jul 20, 2020 | Liq-E S.A. De C.V. | Drugs | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content |
| Jul 20, 2020 | Liq-E S.A. De C.V. | Drugs | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content |
| Jul 20, 2020 | Liq-E S.A. De C.V. | Drugs | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content |
| Jul 16, 2020 | Greenhead Lobster Products | Food | Ready-to-eat lobster meat may be contaminated with Listeria monocytogenes. |
| Jul 15, 2020 | Winter Gardens Quality Foods, Inc. | Food | The product has been recalled due to undeclared (allergen) egg |
| Jul 11, 2020 | 4E Brands North America, Llc | Drugs | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content. |
| Jul 11, 2020 | 4E Brands North America, Llc | Drugs | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content. |
| Jul 11, 2020 | 4E Brands North America, Llc | Drugs | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content. |
| Jul 7, 2020 | CareFusion 213, LLC | Drugs | Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75%… |
| Jul 7, 2020 | CareFusion 213, LLC | Drugs | Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75%… |
| Jul 7, 2020 | CareFusion 213, LLC | Drugs | Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled… |
| Jul 7, 2020 | CareFusion 213, LLC | Drugs | Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV regions of the world where at the labeled… |
| Jul 7, 2020 | Mylan Institutional LLC | Drugs | Presence of Particulate Matter |
| Jul 2, 2020 | AAA Cosmetica, SA De CV | Drugs | Chemical Contamination: Product contains methanol. |
| Jul 1, 2020 | Spartan Chemical Co Inc | Drugs | Microbial contamination of non-sterile products: positive microbial contamination in product. |
Check one company
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