FDA Warning Letters, 483s and Recalls: September 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 |
|---|---|---|---|
| Sep 30, 2020 | China Farms, Inc. | Food/Cosmetics | United States |
| Sep 29, 2020 | Frito Lay Inc | Food/Cosmetics | United States |
| Sep 29, 2020 | Ignacio J. Rodriguez, MD | Drugs | United States |
| Sep 28, 2020 | Catalent Pharma Solutions LLC | Drugs | United States |
| Sep 25, 2020 | Frito-Lay North America, Inc. | Food/Cosmetics | United States |
| Sep 16, 2020 | Purunchon, Inc. | Food/Cosmetics | United States |
| Sep 11, 2020 | UCC Ueshima Coffee Company ( America) Inc | Food/Cosmetics | United States |
| Sep 11, 2020 | World Candy Store 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 | 52 |
| 21 CFR 1.505(b) | Supplier approval - evaluation | 9 |
| 21 CFR 312.60 | FD-1572, protocol compliance | 9 |
| 21 CFR 1.506(b) | Supplier verification - establish written procedures | 8 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 7 |
| 21 CFR 1.506(a)(1) | Unapproved supplier procedures - importer established | 7 |
| FDCA 501(a)(2)(A) | Use of non-pharmaceutical grade components | 7 |
| 21 CFR 117.40 | Equipment and utensils - Design and maintenance | 6 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 6 |
| 21 CFR 117.35(c) | Pest control | 5 |
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 |
|---|---|---|---|
| Sep 25, 2020 | Newly Weds Foods Inc | Food | potentially contaminated with Salmonella |
| Sep 25, 2020 | Newly Weds Foods Inc | Food | potentially contaminated with Salmonella |
| Sep 25, 2020 | Wishgarden Herbs, Incorporated | Drugs | Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. |
| Sep 25, 2020 | Wishgarden Herbs, Incorporated | Drugs | Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. |
| Sep 25, 2020 | Wishgarden Herbs, Incorporated | Drugs | Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. |
| Sep 24, 2020 | Wawona Packing Co LLC Dba Prima Wawona | Food | FDA Sampling during follow-up inspection found Salmonella in peaches and peach leaves. |
| Sep 23, 2020 | Kalustyan Corp. | Food | Possible Salmonella contamination in cinnamon |
| Sep 22, 2020 | Advanced Spice & Trading, Inc. | Food | Potential to be contaminated with Salmonella |
| Sep 22, 2020 | Flexicare Medical Ltd. | Devices | When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance… |
| Sep 21, 2020 | Stryker Neurovascular | Devices | Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use… |
| Sep 21, 2020 | Wismettac Asian Foods, INC | Food | California Department of Public Health sampled and tested Shirakiku brand Black Fungus and found it contain Salmonella ssp. serogroup B. |
| Sep 20, 2020 | Renaissance Food Group LLC | Food | Potential to contain undeclared eggs and milk |
| Sep 17, 2020 | Acella Pharmaceuticals, LLC | Drugs | Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product. |
| Sep 17, 2020 | Acella Pharmaceuticals, LLC | Drugs | Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product. |
| Sep 17, 2020 | Homestead Creamery, Inc. | Food | Product mis-packaging; causing undeclared pecans. |
| Sep 9, 2020 | MEDEK LLC | Drugs | Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol. |
| Sep 4, 2020 | Toufayan Bakery, Inc. | Food | Gluten free product was mixed with wheat containing product. Undeclared Wheat. |
| Sep 3, 2020 | CORGIOMED LLC | Drugs | Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded. |
| Sep 2, 2020 | Tim Campbell Farm LLC | Food | product tested positive for Listeria monocytogenes |
| Sep 1, 2020 | The Protein Shoppe | Drugs | Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile… |
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.