FDA Warning Letters, 483s and Recalls: April 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 |
|---|---|---|---|
| Apr 29, 2020 | Ventura Terra Garden, Inc. | Food/Cosmetics | United States |
| Apr 24, 2020 | KAYMILE TRADING INC | Food/Cosmetics | United States |
| Apr 21, 2020 | GMS International Foods Inc. | Food/Cosmetics | United States |
| Apr 14, 2020 | H&C Food Inc. | Food/Cosmetics | United States |
| Apr 9, 2020 | Medical Center Pharmacy, Inc. | Drugs | United States |
| Apr 6, 2020 | CareFusion 303, Inc. | Devices | United States |
| Apr 3, 2020 | Apollo Health And Beauty Care, Inc. | Drugs | Canada |
| Apr 3, 2020 | Ethnic Specialties 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 | 63 |
| 21 CFR 1.504(a) | Hazard analysis written | 3 |
| 21 CFR 1.505(b) | Supplier approval - document | 2 |
| 21 CFR 1.506(a)(1) | Approved supplier procedures - importer established | 2 |
| 21 CFR 1.506(b) | Supplier verification - establish written procedures | 2 |
| 21 CFR 1.512(b)(1)(i)(A) | Definition very small importer | 2 |
| 21 CFR 1.512(b)(2) | Develop FSVP | 2 |
| 21 CFR 1.512(b)(5)(ii)(A) | Record - English | 2 |
| 21 CFR 803.17 | Lack of Written MDR Procedures | 2 |
| 21 CFR 117.126(a)(1) | Food safety plan | 1 |
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 |
|---|---|---|---|
| Apr 27, 2020 | Condies Foods, Inc. | Food | Undeclared SOY allergen. Wrong ingredient purchased and used. |
| Apr 27, 2020 | Condies Foods, Inc. | Food | Undeclared SOY allergen. Wrong ingredient purchased and used. |
| Apr 22, 2020 | Royal International Trading Inc. | Food | Product contains undeclared sulfites. |
| Apr 20, 2020 | Fresenius Kabi USA, LLC | Drugs | Presence of Particulate Matter - found in reserve sample vials at the firm. |
| Apr 18, 2020 | B. Braun Medical Inc | Drugs | Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers. |
| Apr 18, 2020 | Mellace Family Brands California Inc | Food | Product may contain undeclared milk allergen. |
| Apr 17, 2020 | Freedman Food Service, Inc Dba Buckhead Meat & Seafood Of Houston | Food | Product may contain undeclared Wheat, Soy, Eggs, and Milk |
| Apr 16, 2020 | Whole Foods Market | Food | May contain undeclared cashews (tree nut) |
| Apr 15, 2020 | Summitt Labs | Drugs | Chemical Contamination; product contains elevated levels of lead |
| Apr 14, 2020 | MasterPharm LLC | Drugs | Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil. |
| Apr 10, 2020 | Champlain Chocolate Company | Food | Product contains undeclared milk. |
| Apr 10, 2020 | Whole Foods Market | Food | May contain undeclared milk |
| Apr 7, 2020 | H & C Food Inc. | Food | Product is potentially contaminated with Listeria monocytogenes. |
| Apr 3, 2020 | Heartware, Inc. | Devices | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the… |
| Apr 3, 2020 | Heartware, Inc. | Devices | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the… |
| Apr 3, 2020 | Heartware, Inc. | Devices | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the… |
| Apr 3, 2020 | Heartware, Inc. | Devices | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the… |
| Apr 3, 2020 | Heartware, Inc. | Devices | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the… |
| Apr 1, 2020 | Homestead Creamery, Inc. | Food | Unsalted butter has potential to be contaminated with Listeria monocytogenes. |
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.