FDA Warning Letters, 483s and Recalls: August 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 |
|---|---|---|---|
| Aug 28, 2020 | Swagath Home Foods LLC | Food/Cosmetics | United States |
| Aug 28, 2020 | Thai Kee Corporation | Food/Cosmetics | United States |
| Aug 21, 2020 | Celltrion Branchburg, LLC | Drugs | United States |
| Aug 21, 2020 | Glanbia Nutritionals, Inc. | Food/Cosmetics | United States |
| Aug 13, 2020 | KDunn And Associates, P.A. | Drugs | United States |
| Aug 4, 2020 | E&H Distributors Llc | Food/Cosmetics | United States |
| Aug 4, 2020 | Vibrant Enterprise 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 | 49 |
| 21 CFR 1.505(a)(2) | Evaluation - performance, risk | 10 |
| 21 CFR 1.505(b) | Supplier approval - document | 10 |
| 21 CFR 123.12(a)(2) | Importer verification | 5 |
| 21 CFR 1.504(a) | Hazard analysis written | 5 |
| 21 CFR 1.506(a)(1) | Unapproved supplier procedures - importer established | 5 |
| 21 CFR 1.506(b) | Supplier verification - establish written procedures | 5 |
| 21 CFR 123.6(b) | No HACCP plan | 4 |
| 21 CFR 1.506(d)(1)(i) | Verification activity frequency | 4 |
| 21 CFR 1.510(b)(1) | Record - translate to English | 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 |
|---|---|---|---|
| Aug 31, 2020 | Vascular Solutions, Inc. | Devices | The inner lumen of the Langston catheter may separate from the hub during pressure injection. |
| Aug 31, 2020 | Vascular Solutions, Inc. | Devices | The inner lumen of the Langston catheter may separate from the hub during pressure injection. |
| Aug 31, 2020 | Vascular Solutions, Inc. | Devices | The inner lumen of the Langston catheter may separate from the hub during pressure injection. |
| Aug 31, 2020 | Vascular Solutions, Inc. | Devices | The inner lumen of the Langston catheter may separate from the hub during pressure injection. |
| Aug 27, 2020 | Treehouse Foods | Food | Product may contain undeclared peanut butter. |
| Aug 25, 2020 | Medtronic Vascular | Devices | Subsequent failure of catheters in the field and failed quality testing |
| Aug 25, 2020 | Medtronic Vascular | Devices | Subsequent failure of catheters in the field and failed quality testing |
| Aug 25, 2020 | Medtronic Vascular | Devices | Subsequent failure of catheters in the field and failed quality testing |
| Aug 25, 2020 | RLC Labs Inc. | Drugs | Subpotent Drug: FDA analysis found product to be subpotent |
| Aug 25, 2020 | RLC Labs Inc. | Drugs | Subpotent Drug: FDA analysis found product to be subpotent |
| Aug 25, 2020 | RLC Labs Inc. | Drugs | Subpotent Drug: FDA analysis found product to be subpotent |
| Aug 25, 2020 | RLC Labs Inc. | Drugs | Subpotent Drug: FDA analysis found product to be subpotent |
| Aug 25, 2020 | RLC Labs Inc. | Drugs | Subpotent Drug: FDA analysis found product to be subpotent |
| Aug 25, 2020 | RLC Labs Inc. | Drugs | Subpotent Drug: FDA analysis found product to be subpotent |
| Aug 24, 2020 | Frito-Lay, Inc. | Food | May contain undeclared milk |
| Aug 24, 2020 | Frito-Lay, Inc. | Food | May contain undeclared milk |
| Aug 24, 2020 | Frito-Lay, Inc. | Food | May contain undeclared milk |
| Aug 24, 2020 | Frito-Lay, Inc. | Food | May contain undeclared milk |
| Aug 24, 2020 | Frito-Lay, Inc. | Food | May contain undeclared milk |
| Aug 24, 2020 | Frito-Lay, Inc. | Food | May contain undeclared milk |
| Aug 24, 2020 | Frito-Lay, Inc. | Food | May contain undeclared milk |
| Aug 22, 2020 | Russ Davis Wholesale, LLC | Food | Peach Salsa was made with peaches may be contaminated with Salmonella. |
| Aug 21, 2020 | Frito-Lay, Inc. | Food | May contain undeclared milk |
| Aug 21, 2020 | Wegmans Food Markets, Inc. | Food | Products contain raw peaches that may be contaminated with Salmonella Enteritidis. |
| Aug 21, 2020 | Wegmans Food Markets, Inc. | Food | Products contain raw peaches that may be contaminated with Salmonella Enteritidis. |
| Aug 21, 2020 | Wegmans Food Markets, Inc. | Food | Products contain raw peaches that may be contaminated with Salmonella Enteritidis. |
| Aug 21, 2020 | Wegmans Food Markets, Inc. | Food | Products contain raw peaches that may be contaminated with Salmonella Enteritidis. |
| Aug 21, 2020 | Wegmans Food Markets, Inc. | Food | Products contain raw peaches that may be contaminated with Salmonella Enteritidis. |
| Aug 21, 2020 | Wegmans Food Markets, Inc. | Food | Products contain raw peaches that may be contaminated with Salmonella Enteritidis. |
| Aug 21, 2020 | Wegmans Food Markets, Inc. | Food | Products contain raw peaches that may be contaminated with Salmonella Enteritidis. |
| Aug 21, 2020 | Wegmans Food Markets, Inc. | Food | Products contain raw peaches that may be contaminated with Salmonella Enteritidis. |
| Aug 21, 2020 | Wegmans Food Markets, Inc. | Food | Products contain raw peaches that may be contaminated with Salmonella Enteritidis. |
| Aug 21, 2020 | Wegmans Food Markets, Inc. | Food | Products contain raw peaches that may be contaminated with Salmonella Enteritidis. |
| Aug 21, 2020 | Wegmans Food Markets, Inc. | Food | Products contain raw peaches that may be contaminated with Salmonella Enteritidis. |
| Aug 20, 2020 | Riviana Foods Inc | Food | Undeclared egg. |
| Aug 19, 2020 | Wawona Packing Co LLC Dba Prima Wawona | Food | Trace back information in an outbreak of Salmonella Enteritidis shows peaches from Wawona as likely source of contamination. |
| Aug 18, 2020 | Whole Foods Market | Food | undeclared soy (soy milk) allergen |
| Aug 17, 2020 | ASK Foods Inc | Food | Product may contain undeclared fish (anchovies), milk and soy. |
| Aug 17, 2020 | Maison Terre, LLC | Drugs | Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms… |
| Aug 17, 2020 | Mylan Institutional LLC | Drugs | Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP… |
| Aug 17, 2020 | Mylan Institutional LLC | Drugs | Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP… |
| Aug 14, 2020 | Grupo Asimex De Mexico SA De CV | Drugs | Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content. |
| Aug 14, 2020 | SG24 LLC | Drugs | Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug |
| Aug 14, 2020 | SG24 LLC | Drugs | Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug |
| Aug 14, 2020 | SG24 LLC | Drugs | Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug |
| Aug 14, 2020 | SG24 LLC | Drugs | Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug |
| Aug 14, 2020 | Volu-Sol, Inc. | Drugs | Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label. |
| Aug 11, 2020 | Serafin Fishery | Food | Undeclared allergens (ANCHOVIES, EGGS, MILK AND SOY) |
| Aug 11, 2020 | Serafin Fishery | Food | Undeclared allergens (ANCHOVIES, EGGS, MILK AND SOY) |
| Aug 10, 2020 | Lancaster Foods LLC | Food | Lancaster Foods LLC, 7700 Conowingo Avenue, Jessup, MD 20794 is initiating a recall of products that may have been made with the 500 pounds… |
| Aug 10, 2020 | Progressive Produce LLC | Food | Onions supplied by Thomson Onions were distributed for retail sale. |
| Aug 10, 2020 | Progressive Produce LLC | Food | Onions supplied by Thomson Onions were distributed for retail sale. |
| Aug 10, 2020 | Spokane Produce, Inc. | Food | Salsa products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson International, Inc |
| Aug 10, 2020 | Spokane Produce, Inc. | Food | Salsa products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson International, Inc |
| Aug 10, 2020 | Spokane Produce, Inc. | Food | Salsa products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson International, Inc |
| Aug 10, 2020 | Spokane Produce, Inc. | Food | Salsa products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from Thomson International, Inc |
| Aug 10, 2020 | Whole Foods Market | Food | Undeclared lysozyme (from egg whites) |
| Aug 10, 2020 | Whole Foods Market | Food | Undeclared lysozyme (from egg whites) |
| Aug 10, 2020 | Whole Foods Market | Food | Undeclared lysozyme (from egg whites) |
| Aug 10, 2020 | Whole Foods Market | Food | Undeclared lysozyme (from egg whites) |
| Aug 10, 2020 | Whole Foods Market | Food | Undeclared lysozyme (from egg whites) |
| Aug 10, 2020 | Whole Foods Market | Food | Undeclared lysozyme (from egg whites) |
| Aug 10, 2020 | Whole Foods Market | Food | Undeclared lysozyme (from egg whites) |
| Aug 10, 2020 | Whole Foods Market | Food | Undeclared lysozyme (from egg whites) |
| Aug 10, 2020 | Whole Foods Market | Food | Undeclared lysozyme (from egg whites) |
| Aug 6, 2020 | Haven'S Kitchen | Food | Product is labeled as the wrong sauce, resulting in soy being undeclared on the label. |
| Aug 6, 2020 | Incredible Products, SA De CV | Drugs | Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol. |
| Aug 5, 2020 | The Kroger Co | Food | Potential contamination with Salmonella Newport. |
| Aug 5, 2020 | The Kroger Co | Food | Potential contamination with Salmonella Newport. |
| Aug 5, 2020 | The Kroger Co | Food | Potential contamination with Salmonella Newport. |
| Aug 5, 2020 | The Kroger Co | Food | Potential contamination with Salmonella Newport. |
| Aug 5, 2020 | The Kroger Co | Food | Potential contamination with Salmonella Newport. |
| Aug 5, 2020 | The Kroger Co | Food | Potential contamination with Salmonella Newport. |
| Aug 5, 2020 | The Kroger Co | Food | Potential contamination with Salmonella Newport. |
| Aug 5, 2020 | The Kroger Co | Food | Potential contamination with Salmonella Newport. |
| Aug 5, 2020 | The Kroger Co | Food | Potential contamination with Salmonella Newport. |
| Aug 5, 2020 | The Kroger Co | Food | Potential contamination with Salmonella Newport. |
| Aug 5, 2020 | The Kroger Co | Food | Potential contamination with Salmonella Newport. |
| Aug 5, 2020 | The Kroger Co | Food | Potential contamination with Salmonella Newport. |
| Aug 5, 2020 | The Kroger Co | Food | Potential contamination with Salmonella Newport. |
| Aug 5, 2020 | The Kroger Co | Food | Potential contamination with Salmonella Newport. |
| Aug 5, 2020 | The Kroger Co | Food | Potential contamination with Salmonella Newport. |
| Aug 5, 2020 | The Kroger Co | Food | Potential contamination with Salmonella Newport. |
| Aug 5, 2020 | The Kroger Co | Food | Potential contamination with Salmonella Newport. |
| Aug 5, 2020 | Triple B Corporation | Food | Charlies Produce peeled onions products are recalled due to a potential contamination with Salmonella Newport. |
| Aug 5, 2020 | Triple B Corporation | Food | Charlies Produce peeled onions products are recalled due to a potential contamination with Salmonella Newport. |
| Aug 5, 2020 | Triple B Corporation | Food | Charlies Produce peeled onions products are recalled due to a potential contamination with Salmonella Newport. Onions were supplied from… |
| Aug 4, 2020 | CareFusion 303, Inc. | Devices | Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the… |
| Aug 4, 2020 | CareFusion 303, Inc. | Devices | The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or… |
| Aug 4, 2020 | CareFusion 303, Inc. | Devices | The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the… |
| Aug 4, 2020 | CareFusion 303, Inc. | Devices | The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the… |
| Aug 4, 2020 | Taylor Farms Texas, Inc. | Food | Potential for contamination by Salmonella |
| Aug 4, 2020 | Taylor Farms Texas, Inc. | Food | Potential for contamination by Salmonella |
| Aug 4, 2020 | Taylor Farms Texas, Inc. | Food | Potential for contamination by Salmonella |
| Aug 4, 2020 | Taylor Farms Texas, Inc. | Food | Potential for contamination by Salmonella |
| Aug 4, 2020 | Taylor Farms Texas, Inc. | Food | Potential for contamination by Salmonella |
| Aug 4, 2020 | Taylor Farms Texas, Inc. | Food | Potential for contamination by Salmonella |
| Aug 4, 2020 | Taylor Farms Texas, Inc. | Food | Potential for contamination by Salmonella |
| Aug 3, 2020 | Spokane Produce, Inc. | Food | Salmonella Newport. Product contains onion supplied from Thomson International, Inc. |
| Aug 3, 2020 | Spokane Produce, Inc. | Food | Salmonella Newport. Product contains onion supplied from Thomson International, Inc. |
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