FDA Warning Letters, 483s and Recalls: November 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 |
|---|---|---|---|
| Nov 25, 2020 | Michael L. Levin, M.D. | Biologics | United States |
| Nov 25, 2020 | Russ Davis Wholesale, Inc. | Food/Cosmetics | United States |
| Nov 24, 2020 | Neil Sheth, MD | Biologics | United States |
| Nov 23, 2020 | Allure Labs, LLC | Drugs | United States |
| Nov 17, 2020 | 88 Special Sweet, Inc. | Food/Cosmetics | United States |
| Nov 12, 2020 | Kradjian Importing Company, Inc. | Food/Cosmetics | United States |
| Nov 10, 2020 | JR & Son World Trading LLC | Food/Cosmetics | United States |
| Nov 10, 2020 | Sirob Imports, Inc. | Food/Cosmetics | United States |
| Nov 9, 2020 | Alma Reserve | Food/Cosmetics | United States |
| Nov 5, 2020 | Novel Laboratories, Inc. | Drugs | United States |
| Nov 4, 2020 | Bob Gosman Co., Inc. | Food/Cosmetics | United States |
| Nov 2, 2020 | Panther James 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) | Develop FSVP | 34 |
| 21 CFR 1.506(a)(1) | Unapproved supplier procedures - importer established | 8 |
| 21 CFR 117.130(a)(1) | Hazard Analysis - Identification of Hazard | 5 |
| 21 CFR 1.505(b) | Supplier approval - document | 5 |
| 21 CFR 1.505(a)(2) | Evaluation - performance, risk | 4 |
| 21 CFR 1.506(b) | Supplier verification - establish written procedures | 4 |
| 21 CFR 312.60 | FD-1572, protocol compliance | 4 |
| 21 CFR 312.62(b) | Case history records- inadequate or inadequate | 4 |
| 21 CFR 117.10 | Personnel | 3 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 3 |
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 |
|---|---|---|---|
| Nov 26, 2020 | Veg Pro International Inc | Food | Spinach may be contaminated with Salmonella |
| Nov 25, 2020 | Torrent Pharma Inc | Drugs | Failed Dissolution Specifications |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Cook Inc. | Devices | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could… |
| Nov 24, 2020 | Hy-Vee Stores Inc | Food | An ingredient used as an ingredient in the products tested positive for Listeria monocytogenes |
| Nov 24, 2020 | Hy-Vee Stores Inc | Food | An ingredient used as an ingredient in the products tested positive for Listeria monocytogenes |
| Nov 23, 2020 | PRAIRIE FARMS | Food | The product contains undeclared egg. |
| Nov 23, 2020 | PRAIRIE FARMS | Food | The product contains undeclared egg. |
| Nov 23, 2020 | Whole Foods Market | Food | Undeclared allergen (shrimp) due to product mislabeling. |
| Nov 21, 2020 | Dole Fresh Vegetables Inc | Food | Pathogenic non-O157 E.coli STEC found during routine sampling by Michigan Department of Agriculture and Rural Development. |
| Nov 19, 2020 | Heartware, Inc. | Devices | Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a… |
| Nov 18, 2020 | Hong Thai Foods Corp | Food | Product contain undeclared milk. |
| Nov 18, 2020 | Hong Thai Foods Corp | Food | Products contain undeclared milk and Uranine-Acid Yellow 73 |
| Nov 17, 2020 | Boston Scientific Corporation | Devices | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to… |
| Nov 17, 2020 | Boston Scientific Corporation | Devices | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to… |
| Nov 17, 2020 | Boston Scientific Corporation | Devices | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to… |
| Nov 17, 2020 | Boston Scientific Corporation | Devices | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to… |
| Nov 17, 2020 | Boston Scientific Corporation | Devices | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to… |
| Nov 17, 2020 | Boston Scientific Corporation | Devices | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to… |
| Nov 17, 2020 | Fresenius Kabi USA, LLC | Drugs | Cross Contamination with other products: trace amounts of lidocaine |
| Nov 17, 2020 | MPM Medical LLC | Drugs | Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia. |
| Nov 16, 2020 | Fresh Express Incorpated | Food | Fresh Express Kit Caesar Supreme bagged salad potentially contaminated with Escherichia coli STEC O26. |
| Nov 13, 2020 | Boston Scientific Corporation | Devices | There is potential for fractures which results in the inability to delivery therapy. |
| Nov 13, 2020 | Kanan Enterprises Inc. | Food | Almonds were found inside packages which do not state they contain almonds. |
| Nov 10, 2020 | High Quality Organics | Food | Potential Salmonella contamination. |
| Nov 6, 2020 | Quantum Inc | Food | Product recalled due to potential contamination of Salmonella. |
| Nov 6, 2020 | Tanimura & Antle | Food | Michigan Department of Agriculture and Rural Development found E.coli O157:H7 in romaine lettuce during routine sampling. |
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