FDA Warning Letters, 483s and Recalls: January 2021
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.
| Date | Company | Issuing office | Subject |
|---|---|---|---|
| Jan 29, 2021 | Ignacio J. Rodriguez, MD | Center for Drug Evaluation and Research | CDER | Clinical Investigator |
| Jan 29, 2021 | UCC Ueshima Coffee Company America Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Jan 28, 2021 | Buy-Pharma.Md | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jan 28, 2021 | Rx2Go.Com | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jan 28, 2021 | Sandra-Pharma.Is | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jan 28, 2021 | Simex Logistics S.A. De C.V. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Jan 27, 2021 | Allay Pharmaceuticals, LLC | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated |
| Jan 27, 2021 | Professional Compounding Centers Of America Dba PCCA | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Jan 26, 2021 | Grupo Yacana Mexico, S.A.S. De C.V. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Jan 25, 2021 | EnMed MicroAnalytics, Inc. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jan 25, 2021 | Grupo Plast-Y-Kosas, SA De CV | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Jan 25, 2021 | Ignacio Reyes Gonzalez | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Jan 25, 2021 | Laboratorios Jaloma S.A. De C.V. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Jan 25, 2021 | PYRLess Group, LLC Dba Dr. Fitt | Center for Food Safety and Applied Nutrition | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jan 22, 2021 | American Global Health Group, LLC | Division of Human and Animal Food Operations West VI | New Drug/Misbranded |
| Jan 22, 2021 | Yuyao YiJia Daily Chemical Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Jan 20, 2021 | Woobo LLC Dba Purunchon Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Jan 19, 2021 | Alma Reserve | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Jan 14, 2021 | Sage Moon Apothecary LLC | Division of Human and Animal Food Operations East I | New Drug/Misbranded |
| Jan 12, 2021 | Allimax Us | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jan 12, 2021 | AusarHerbs | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Jan 8, 2021 | Thai Kee Trading Co | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Jan 6, 2021 | Entia Biosciences, Inc | Division of Human and Animal Food Operations West VI | New Drug/Misbranded |
| Jan 4, 2021 | Coco's Holistic Specialties & Apothecary | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
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 |
|---|---|---|---|
| Jan 29, 2021 | Imprimis NJOF, LLC | Drugs | United States |
| Jan 28, 2021 | MR LUKAS LLC | Food/Cosmetics | United States |
| Jan 27, 2021 | Gourmet And More Inc. | Food/Cosmetics | United States |
| Jan 27, 2021 | Sunrise International Group | Food/Cosmetics | United States |
| Jan 26, 2021 | NEM ADVISORS LLC/SHOP&SAVE MARKET | Food/Cosmetics | United States |
| Jan 21, 2021 | KAREEM MART INC | Food/Cosmetics | United States |
| Jan 21, 2021 | Wa Heng Dou-Fu And Soy Sauce Corporation | Food/Cosmetics | United States |
| Jan 21, 2021 | Wa Heng Dou Fu Soy Sauce Corporation Laboratory | Food/Cosmetics | United States |
| Jan 20, 2021 | Dental Technologies, Inc. | Drugs | United States |
| Jan 20, 2021 | D.K.GROCERY INC | Food/Cosmetics | United States |
| Jan 20, 2021 | K D Singh Enterprises LLC | Food/Cosmetics | United States |
| Jan 19, 2021 | J & L Usa Inc. | Food/Cosmetics | United States |
| Jan 14, 2021 | IMAD International, LLC | Food/Cosmetics | United States |
| Jan 14, 2021 | Market Of Choice Inc | Food/Cosmetics | United States |
| Jan 6, 2021 | Dilip Ceramics Inc. | 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 | 58 |
| 21 CFR 117.130(a)(1) | Hazard Analysis - Identification of Hazard | 8 |
| 21 CFR 117.150(a)(1) | Sanitation Controls Corrective Action Proced: Estab Implemnt | 6 |
| 21 CFR 117.165(b) | Sanitation Controls Verif Procedures: Establish Implement | 5 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 5 |
| 21 CFR 1.505(b) | Supplier approval - document | 5 |
| 21 CFR 1.506(a)(1) | Approved supplier procedures - importer established | 5 |
| 21 CFR 1.506(b) | Supplier verification - establish written procedures | 5 |
| 21 CFR 312.60 | FD-1572, protocol compliance | 5 |
| 21 CFR 117.145(a) | Sanitation Controls Monitoring Proced: Establish Implement | 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 |
|---|---|---|---|
| Jan 28, 2021 | Dole Fresh Vegetables Inc | Food | Two consumer complaints received for incorrect Master pack in Endless Summer salad kit - undeclared fish and eggs in Caesar dressing that… |
| Jan 27, 2021 | Bryant Ranch Prepack, Inc. Dba BRP Pharmaceuticals | Drugs | Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets. |
| Jan 27, 2021 | Meitheal Pharmaceuticals Inc | Drugs | Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine… |
| Jan 26, 2021 | Hong Thai Foods Corp | Food | Muffin contains undeclared milk discovered via NY state sampling. |
| Jan 26, 2021 | Maine Grains, Inc | Food | Product contains undeclared soy. |
| Jan 22, 2021 | Acist Medical Systems | Devices | Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing… |
| Jan 21, 2021 | Frito-Lay, Inc. Headquarters | Food | Potential to contain undeclared milk |
| Jan 15, 2021 | Calvin Scott & Company, Inc. | Drugs | Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as… |
| Jan 5, 2021 | Dole Fresh Vegetables Inc | Food | Incorrect product master-pack label causing an undeclared allergen; egg. |
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.