FDA Warning Letters, 483s and Recalls: May 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 |
|---|---|---|---|
| May 28, 2020 | Fides New York Inc | Food/Cosmetics | United States |
| May 26, 2020 | WCS Trading, Inc. | Food/Cosmetics | United States |
| May 19, 2020 | OCM GROUP USA INC | Food/Cosmetics | United States |
| May 18, 2020 | Fresenius Kabi USA LLC | Drugs | United States |
| May 15, 2020 | Allay Pharmaceuticals, LLC | Drugs | United States |
| May 8, 2020 | BABYLON INC | Food/Cosmetics | United States |
| May 6, 2020 | Grupo Rm Usa, Inc. | Food/Cosmetics | United States |
| May 5, 2020 | Canyon Farms, 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) | Maintain, follow FSVP | 59 |
| 21 CFR 1.504(a) | Hazard analysis written | 5 |
| 21 CFR 1.505(b) | Supplier approval - document | 5 |
| 21 CFR 1.506(a)(1) | Unapproved supplier procedures - importer established | 5 |
| 21 CFR 1.506(d)(1)(i) | Verification activity frequency | 4 |
| 21 CFR 1.504(c)(1) | Evaluation severity | 3 |
| 21 CFR 1.505(a)(2) | Evaluation - performance, risk | 3 |
| 21 CFR 1.512(b)(2) | Develop FSVP | 3 |
| 21 CFR 108.25(c)(2) | Process filing | 2 |
| 21 CFR 117.145(a) | Process Controls Monitoring Procedures: Establish Implement | 2 |
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 |
|---|---|---|---|
| May 22, 2020 | Acella Pharmaceuticals, LLC | Drugs | Superpotent Drug. |
| May 22, 2020 | Acella Pharmaceuticals, LLC | Drugs | Superpotent Drug. |
| May 22, 2020 | Acella Pharmaceuticals, LLC | Drugs | Superpotent Drug. |
| May 21, 2020 | Captain Rusty's Seafood Products LLC | Food | Undeclared major allergens (fish, egg, soy, milk, and wheat) in "Captain Rusty's" brand Blue Crab Dip uncovered during FDACS routine… |
| May 21, 2020 | Captain Rusty's Seafood Products LLC | Food | Undeclared major allergens (fish, egg, soy, milk, wheat, and crustacean shellfish) in "Captain Rusty's" brand Cajun Crab & Lobster Dip… |
| May 21, 2020 | Captain Rusty's Seafood Products LLC | Food | Undeclared major allergens (fish, egg, soy, milk, wheat, and crustacean shellfish) in "Captain Rusty's" brand Lobster Dip uncovered during… |
| May 21, 2020 | Captain Rusty's Seafood Products LLC | Food | Undeclared major allergens (egg and soy) in "Captain Rusty's" brand Smoked Mahi Dip uncovered during FDACS routine inspection. |
| May 20, 2020 | Arrow International Inc | Devices | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within… |
| May 20, 2020 | Arrow International Inc | Devices | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within… |
| May 20, 2020 | Arrow International Inc | Devices | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within… |
| May 20, 2020 | Arrow International Inc | Devices | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within… |
| May 20, 2020 | Arrow International Inc | Devices | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within… |
| May 20, 2020 | Arrow International Inc | Devices | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within… |
| May 20, 2020 | Arrow International Inc | Devices | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within… |
| May 20, 2020 | Arrow International Inc | Devices | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within… |
| May 20, 2020 | Arrow International Inc | Devices | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within… |
| May 20, 2020 | Arrow International Inc | Devices | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within… |
| May 19, 2020 | BAKE'N JOY FOODS, INC. | Food | Product may contain undeclared walnuts. |
| May 14, 2020 | New Hoque & Sons, Inc. | Food | Curry powder is contaminated with Salmonella spp. detected by FDA sampling. |
| May 14, 2020 | Ventura Foods Llc | Food | Undeclared Milk and Wheat in labeling. |
| May 12, 2020 | Medtronic Vascular Galway DBA Medtronic Ireland | Devices | Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection) |
| May 12, 2020 | Ramar International Corporation | Food | Ice cream that tested positive for Listeria monocytogenes was to be held and destroyed but was found on retail shelves. |
| May 8, 2020 | ICU Medical Inc | Drugs | Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide. |
| May 8, 2020 | K F K Seasonings Llc | Food | Undeclared tree nuts and Crustacea. |
| May 8, 2020 | K F K Seasonings Llc | Food | Undeclared tree nuts and Crustacea. |
| May 8, 2020 | K F K Seasonings Llc | Food | Undeclared tree nuts |
| May 6, 2020 | Endologix, Inc. | Devices | A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks… |
| May 1, 2020 | Jason Pharmaceuticals, Inc. T/A Medifast | Food | The product contains undeclared milk. |
| May 1, 2020 | Mondelez Global Llc | Food | The firm is recalling a limited quantity of RITZ Cheese Cracker Sandwiches Family Size (21.6 oz. carton) product in the United States… |
Check one company
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