FDA Warning Letters, 483s and Recalls: December 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 |
|---|---|---|---|
| Dec 23, 2020 | GLOBAL TRADE BRIDGE CORP. | Food/Cosmetics | United States |
| Dec 23, 2020 | Sky Global Food Inc | Food/Cosmetics | United States |
| Dec 21, 2020 | Avalon Packaging, Inc. | Food/Cosmetics | United States |
| Dec 17, 2020 | Aman Kapoor Inc | Food/Cosmetics | United States |
| Dec 17, 2020 | Corporacion Avicola Morovis, Inc. | Food/Cosmetics | United States |
| Dec 17, 2020 | Lewiston Feed & Produce Company | Veterinary | United States |
| Dec 17, 2020 | Tropical Bakery Wholesale Corp | Food/Cosmetics | United States |
| Dec 8, 2020 | Battelle Biomedical Research Center | Devices | United States |
| Dec 8, 2020 | Battelle Boston CCDS Site | Devices | United States |
| Dec 8, 2020 | Battelle CCDS Detroit | Devices | United States |
| Dec 4, 2020 | Daisy Global Trading Co | Food/Cosmetics | United States |
| Dec 3, 2020 | Consider Bardwell Farm, LLC | Food/Cosmetics | United States |
| Dec 3, 2020 | K & K Distribution, Inc. | Food/Cosmetics | United States |
| Dec 3, 2020 | Panjin Hetian Food Co., Ltd. | Food/Cosmetics | China |
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) | Develop FSVP | 62 |
| 21 CFR 1.505(a)(2) | Evaluation - performance, risk | 9 |
| 21 CFR 1.504(a) | Hazard analysis written | 8 |
| 21 CFR 117.165(b) | Sanitation Controls Verif Procedures: Establish Implement | 6 |
| 21 CFR 1.505(b) | Supplier approval - document | 6 |
| 21 CFR 1.506(a)(1) | Unapproved supplier procedures - importer established | 6 |
| 21 CFR 1.506(d)(1)(i) | Verification activity frequency | 6 |
| 21 CFR 1.506(e)(1) | Verification activity before import, periodically | 5 |
| 21 CFR 312.60 | Informed consent | 5 |
| 21 CFR 1.506(b) | Supplier verification - establish written procedures | 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 |
|---|---|---|---|
| Dec 31, 2020 | Rhino Foods, Inc. | Food | Cookie dough ingredient intended for use in ice cream may be contaminated with Listeria monocytogenes. |
| Dec 29, 2020 | Divvies LLC | Food | Cupcakes contain undeclared milk and egg due to supplier ingredient. |
| Dec 29, 2020 | Divvies LLC | Food | Cupcakes contain undeclared milk and egg due to supplier ingredient. |
| Dec 28, 2020 | Hill Pharma Inc | Food | Possible salmonella worthington contamination in pea protein |
| Dec 24, 2020 | Lipari Foods Operating Company, LLC. | Food | Undeclared Allergens: Milk |
| Dec 23, 2020 | B & I Overseas Trading Inc. | Food | Washington State Department of Agriculture samples product and had a positive result of Listeria monocytogenes. |
| Dec 23, 2020 | Combat Medical Systems, LLC | Devices | There is the potential of a bent or disconnected needle in one of the components of the convenience kits. |
| Dec 23, 2020 | Combat Medical Systems, LLC | Devices | There is the potential of a bent or disconnected needle in one of the components of the convenience kits. |
| Dec 23, 2020 | Combat Medical Systems, LLC | Devices | There is the potential of a bent or disconnected needle in one of the components of the convenience kits. |
| Dec 23, 2020 | Combat Medical Systems, LLC | Devices | There is the potential of a bent or disconnected needle in one of the components of the convenience kits. |
| Dec 23, 2020 | Combat Medical Systems, LLC | Devices | There is the potential of a bent or disconnected needle in one of the components of the convenience kits. |
| Dec 23, 2020 | Fresenius Kabi USA, LLC | Drugs | Presence of Particulate Matter - found in reserve sample vials at the firm. |
| Dec 22, 2020 | American Blue Ribbon Holdings LLC | Food | Undeclared Pecan |
| Dec 22, 2020 | B&G Foods North America, Inc | Food | B&G Foods, Inc. has initiated a recall because their garlic powder mistakenly had bacon-flavored bits, which contain soy, an allergen… |
| Dec 22, 2020 | GH Foods CA LLC | Food | Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight… |
| Dec 22, 2020 | GH Foods CA LLC | Food | Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight… |
| Dec 22, 2020 | GH Foods CA LLC | Food | Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight… |
| Dec 22, 2020 | GH Foods CA LLC | Food | Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight… |
| Dec 22, 2020 | GH Foods CA LLC | Food | Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight… |
| Dec 22, 2020 | GH Foods CA LLC | Food | Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight… |
| Dec 18, 2020 | Hill-Rom, Inc. | Devices | Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, leading to the Multirall lift becoming… |
| Dec 18, 2020 | JR Simplot Company - Headquarters | Food | Undeclared wheat. |
| Dec 17, 2020 | NDAL Mfg Inc. | Drugs | Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast |
| Dec 16, 2020 | TESOROS TRADING CO. | Food | Firm routine testing resulted in a positive result for Listeria monocytogenes in one bag of frozen edamame. |
| Dec 15, 2020 | Penumbra Inc. | Devices | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast… |
| Dec 15, 2020 | Penumbra Inc. | Devices | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast… |
| Dec 15, 2020 | Penumbra Inc. | Devices | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast… |
| Dec 15, 2020 | Penumbra Inc. | Devices | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast… |
| Dec 7, 2020 | AVKARE Inc. | Drugs | Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility. |
| Dec 5, 2020 | George DeLallo Co. Inc. New Stanton Warehouse And Production | Food | Undeclared pecans due to mis-labeling |
| Dec 4, 2020 | Market Of Choice Inc | Food | Sour Cherry Baked Brie was recalled because the scale label, which was printed at retail stores, do not list almond. |
| Dec 3, 2020 | Treehouse Foods | Food | The firm was notified via a consumer complaint that the product contains the Lite Honey Mustard instead of the regular Honey Mustard. The… |
| Dec 2, 2020 | Boston Scientific Corporation | Devices | Electrical overstress may lead to device malfunction. |
| Dec 2, 2020 | Boston Scientific Corporation | Devices | Electrical overstress may lead to device malfunction. |
| Dec 1, 2020 | Maribel's Sweets, Inc. | Food | Product contains undeclared milk. |
Check one company
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