FDA Warning Letters, 483s and Recalls: August 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 |
|---|---|---|---|
| Aug 31, 2021 | 247Rxpill.In | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Aug 31, 2021 | New York Nutrition Company / American Metabolix | Division of Human and Animal Food Operations West III | Unapproved New Drugs/Misbranded |
| Aug 31, 2021 | PowerAll Pharma | United States | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Aug 30, 2021 | Ebenezer International Food, LLC | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 26, 2021 | Fibromyalgia Treatment Group - FTG, LLC | Division of Human and Animal Food Operations West VI | New Drug/Misbranded |
| Aug 26, 2021 | Infusion Options, Inc. | Division of Pharmaceutical Quality Operations I | Compounding Pharmacy/Adulterated Drug Products |
| Aug 26, 2021 | Kaleido Biosciences, Inc. | Center for Drug Evaluation and Research | CDER | Bioresearch Monitoring Program |
| Aug 24, 2021 | Invisi Smart Technologies UK LTD | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 |
| Aug 19, 2021 | Mahita, LLC Dba PushMyCart | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Aug 19, 2021 | Toyobo Co. Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 18, 2021 | AnazaoHealth Corporation | Division of Pharmaceutical Quality Operations IV | Compounding Pharmacy/Adulterated Drug Products |
| Aug 17, 2021 | Adamson Analytical Laboratories, Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
| Aug 16, 2021 | Akshar Sales LLC | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 11, 2021 | Je Dois Lavoir LLC | Division of Pharmaceutical Quality Operations IV | Unapproved New Drugs/Misbranded |
| Aug 10, 2021 | Secret Of The Islands | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Aug 10, 2021 | Tropicosmeticos SA De CV | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Aug 10, 2021 | Utah Cord Bank LLC Dba Utah Cell Bank | Office of Biological Products Operations - Division 2 | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Aug 9, 2021 | Midwestern Pet Food | Center for Veterinary Medicine | CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Aug 9, 2021 | Pairon Solutions LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Aug 6, 2021 | Blue Poppy Enterprises Inc | Division of Human and Animal Food Operations West VI | New Drug/Misbranded |
| Aug 6, 2021 | Genesis Nutrition Ultra Slim Dba Genesis Ultra Slim | Office of Pharmaceutical Quality Operations, Division II | Unapproved New Drugs/Misbranded |
| Aug 6, 2021 | Maitland Labs Of Central Florida | Office of Pharmaceutical Quality Operations, Division II | Compounding Pharmacy/Adulterated Drug Products |
| Aug 4, 2021 | BBC Group Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| Aug 4, 2021 | Garden Fresh Market | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 3, 2021 | Blue Willow Biologics | Center for Drug Evaluation and Research | Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) |
| Aug 3, 2021 | Productos Bredy USA LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Aug 2, 2021 | Pharmaceutical Care Solutions Dba Pharmacy Solutions | Division of Pharmaceutical Quality Operations III | Compounding Pharmacy/Adulterated Drug Products |
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 |
|---|---|---|---|
| Aug 31, 2021 | Accu Bio-Chem Laboratories LLC | Drugs | United States |
| Aug 31, 2021 | La Nica Products, Inc. | Food/Cosmetics | United States |
| Aug 31, 2021 | Teligent Pharma, Inc. | Drugs | United States |
| Aug 27, 2021 | Bakery Project, Inc. | Food/Cosmetics | United States |
| Aug 27, 2021 | New Vitalis Pharmacy LLC | Drugs | United States |
| Aug 27, 2021 | Product Packaging West, Inc. | Drugs | United States |
| Aug 27, 2021 | University General Hospital Of Ioannina | Drugs | Greece |
| Aug 26, 2021 | Aroma Imports, Inc. | Food/Cosmetics | United States |
| Aug 26, 2021 | VHRK FOOD INC. | Food/Cosmetics | United States |
| Aug 25, 2021 | DeVilbiss Healthcare LLC | Devices | United States |
| Aug 25, 2021 | Etai's Food, LLC. | Food/Cosmetics | United States |
| Aug 25, 2021 | HK Produce Group Inc | Food/Cosmetics | United States |
| Aug 25, 2021 | Joy Gourmet Foods LLC. | Food/Cosmetics | United States |
| Aug 25, 2021 | SERGIO CARRANZA | Food/Cosmetics | United States |
| Aug 25, 2021 | The Skin Atelier, Inc. | Drugs | United States |
| Aug 24, 2021 | Blaine Labs Inc | Drugs | United States |
| Aug 23, 2021 | Advanced Pharmaceutical Technology, Inc. | Drugs | United States |
| Aug 20, 2021 | Belleview 402 LLC | Drugs | United States |
| Aug 20, 2021 | Bodyhealth.Com, LLC | Food/Cosmetics | United States |
| Aug 20, 2021 | Monarch PCM, LLC | Drugs | United States |
| Aug 20, 2021 | RNV LLC | Drugs | United States |
| Aug 20, 2021 | Smitha Reddy, M.D. | Drugs | United States |
| Aug 20, 2021 | Sunny Creek Farm Inc. | Food/Cosmetics | United States |
| Aug 20, 2021 | Teva Parenteral Medicines, Inc. | Drugs | United States |
| Aug 19, 2021 | Fides New York Inc | Food/Cosmetics | United States |
| Aug 19, 2021 | Washington Homeopathic Products, Inc. | Veterinary | United States |
| Aug 18, 2021 | Hammond & Co, Inc | Drugs | United States |
| Aug 17, 2021 | Ceba-Tek, Inc. | Food/Cosmetics | United States |
| Aug 13, 2021 | Biomic Sciences, LLC | Food/Cosmetics | United States |
| Aug 13, 2021 | Dinamix Distribution, LLC. | Food/Cosmetics | United States |
| Aug 13, 2021 | Tropic Trading Co. | Food/Cosmetics | United States |
| Aug 12, 2021 | Apitoria Pharma Private Limited | Drugs | India |
| Aug 12, 2021 | Coupler LLC | Drugs | United States |
| Aug 12, 2021 | Hetero Labs Limited | Drugs | India |
| Aug 12, 2021 | Prescription Labs Inc | Drugs | United States |
| Aug 12, 2021 | Rip It Vapors | Tobacco | United States |
| Aug 11, 2021 | First Royal Care Co. LLC | Drugs | United States |
| Aug 11, 2021 | Tropical Bakery Wholesale Corp | Food/Cosmetics | United States |
| Aug 7, 2021 | Indiana Chem-Port | Drugs | India |
| Aug 6, 2021 | Lea-Way Farms Inc. | Veterinary | United States |
| Aug 6, 2021 | Revive Rx LLC | Drugs | United States |
| Aug 5, 2021 | CureWave Lasers, LLC | Devices | United States |
| Aug 5, 2021 | DSAART LLC | Devices | United States |
| Aug 5, 2021 | Maggie A. Jeffries, M.D. | Drugs | United States |
| Aug 4, 2021 | Vevazz LLC | Devices | United States |
| Aug 3, 2021 | Aplicare Products, LLC | Drugs | United States |
| Aug 3, 2021 | Concord Farms, Inc. | Food/Cosmetics | United States |
| Aug 2, 2021 | IntegraDose Compounding Services LLC | Drugs | 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 | 83 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 21 |
| 21 CFR 117.35(c) | Pest control | 19 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 19 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 17 |
| 21 CFR 117.40 | Equipment and utensils - Design and maintenance | 16 |
| 21 CFR 123.6(b) | No HACCP plan | 15 |
| 21 CFR 117.10 | Personnel | 14 |
| 21 CFR 117.130(a)(1) | Hazard Analysis - Identification of Hazard | 14 |
| 21 CFR 1.506(a)(1) | Approved supplier procedures - importer established | 14 |
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 |
|---|---|---|---|
| Aug 30, 2021 | KBF INC | Food | contains undeclared milk |
| Aug 27, 2021 | DuPont Nutrition USA, Inc | Drugs | Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC). |
| Aug 27, 2021 | North Coast Medical Inc | Devices | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA… |
| Aug 27, 2021 | North Coast Medical Inc | Devices | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA… |
| Aug 25, 2021 | Accelerated Care Plus Corporation | Devices | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA… |
| Aug 24, 2021 | Azurity Pharmaceuticals, Inc. | Drugs | Product Mix-up: Incorrect diluent component included in the kit. |
| Aug 24, 2021 | National Distribution & Contracting Inc | Devices | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. |
| Aug 24, 2021 | National Distribution & Contracting Inc | Devices | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. |
| Aug 23, 2021 | Aesthetics Systems Usa Inc | Devices | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA… |
| Aug 23, 2021 | Joy Gourmet Foods LLC. | Food | Product contains high levels of undeclared sulfites. |
| Aug 23, 2021 | Loki Fish Company - Office | Food | Potential to be contaminated with Listeria monocytogenes. |
| Aug 20, 2021 | Athena Medical Products Inc | Devices | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA… |
| Aug 20, 2021 | Athena Medical Products Inc | Devices | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA… |
| Aug 19, 2021 | Windstone Medical Packaging, Inc. | Devices | Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back… |
| Aug 18, 2021 | Phe Inc | Drugs | Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. |
| Aug 18, 2021 | Scrip Inc | Devices | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. |
| Aug 18, 2021 | Scrip Inc | Devices | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. |
| Aug 13, 2021 | IMPERATIVE CARE INC | Devices | There is a potential for distal end of catheters to fracture and become detached. |
| Aug 12, 2021 | AMTEC SALES Inc | Devices | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. |
| Aug 11, 2021 | Ebay Seller - John Nguyen | Drugs | Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine |
| Aug 11, 2021 | Frito-Lay, Inc. Headquarters | Food | May contain undeclared milk |
| Aug 11, 2021 | Red Medical Supplies | Devices | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA… |
| Aug 11, 2021 | Red Medical Supplies | Devices | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA… |
| Aug 11, 2021 | Red Medical Supplies | Devices | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA… |
| Aug 10, 2021 | Ballreich Snack Food Company, LLC | Food | Ingredient used possibly contaminated with Salmonella |
| Aug 10, 2021 | SterRx, LLC | Drugs | Non-Sterility: firm's third party lab confirmed microbial contamination. |
| Aug 9, 2021 | Jimmy's Cookies, LLC | Food | Undeclared allergen - Peanuts. |
| Aug 9, 2021 | Mane Inc | Food | Ingredient used in manufacturing tested positive for Salmonella |
| Aug 9, 2021 | Mane Inc | Food | Ingredient used in manufacturing tested positive for Salmonella |
| Aug 9, 2021 | Mane Inc | Food | Ingredient used in manufacturing tested positive for Salmonella |
| Aug 8, 2021 | Able Groupe Inc | Food | The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1… |
| Aug 8, 2021 | Able Groupe Inc | Food | The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1… |
| Aug 8, 2021 | Able Groupe Inc | Food | The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1… |
| Aug 8, 2021 | Able Groupe Inc | Food | The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1… |
| Aug 8, 2021 | Able Groupe Inc | Food | The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1… |
| Aug 8, 2021 | Able Groupe Inc | Food | The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1… |
| Aug 8, 2021 | Able Groupe Inc | Food | The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1… |
| Aug 8, 2021 | Able Groupe Inc | Food | The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1… |
| Aug 6, 2021 | Smiths Medical ASD Inc. | Devices | There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer… |
| Aug 6, 2021 | Smiths Medical ASD Inc. | Devices | There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer… |
| Aug 5, 2021 | Armstrong Medical Services Limited | Devices | Some devices may be associated with high and unexpected resistance to gas flow during clinical use, impacting or preventing adequate… |
| Aug 4, 2021 | Cardinal Health | Devices | Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe. |
| Aug 4, 2021 | Cardinal Health | Devices | Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe. |
| Aug 4, 2021 | Cardinal Health | Devices | Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe. |
| Aug 4, 2021 | DSD Merchandisers, Inc. | Food | Firm notified by customers that product labeled as Dark Chocolate Malt Balls had Dark Chocolate Peanut Butter malt balls inside… |
| Aug 4, 2021 | Mac Medical Supply Co Inc | Devices | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. |
| Aug 3, 2021 | Teligent Pharma, Inc. | Drugs | Superpotent Drug |
| Aug 2, 2021 | Golden Natural Products | Food | Product contains high levels of undeclared sulfites. |
| Aug 2, 2021 | Je Dois Lavoir LLC | Drugs | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug… |
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