FDA Warning Letters, 483s and Recalls: June 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 |
|---|---|---|---|
| Jun 29, 2020 | V-NINE INC | Food/Cosmetics | United States |
| Jun 23, 2020 | Evelyn Lopez-Brignoni, M.D. | Drugs | United States |
| Jun 15, 2020 | MasterPharm LLC | Drugs | United States |
| Jun 11, 2020 | DN Imports, Inc | Food/Cosmetics | United States |
| Jun 10, 2020 | Aspen Sales Group | Food/Cosmetics | United States |
| Jun 9, 2020 | Gns Sales Llc | Food/Cosmetics | United States |
| Jun 1, 2020 | Gourmet And More 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 | 51 |
| 21 CFR 1.506(a)(1) | Unapproved supplier procedures - importer established | 8 |
| 21 CFR 1.512(b)(2) | Develop FSVP | 6 |
| 21 CFR 1.504(a) | Hazard analysis written | 5 |
| 21 CFR 1.505(b) | Supplier approval - document | 4 |
| 21 CFR 1.506(d)(1)(i) | Verification activity frequency | 4 |
| 21 CFR 1.504(b)(1) | Hazard analysis biological, chemical, physical | 3 |
| 21 CFR 1.504(d) | Review entity's hazard analysis | 3 |
| 21 CFR 1.505(a)(2) | Evaluation - performance, risk | 3 |
| 21 CFR 1.506(b) | Supplier verification - establish written procedures | 3 |
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 |
|---|---|---|---|
| Jun 30, 2020 | Baxter Healthcare Corporation | Devices | Baxter is updating the device IFU for safety communication regarding cleaning practices. |
| Jun 30, 2020 | Baxter Healthcare Corporation | Devices | Baxter is updating the device IFU for safety communication regarding cleaning practices. |
| Jun 30, 2020 | Baxter Healthcare Corporation | Devices | Baxter is updating the device IFU for safety communication regarding cleaning practices. |
| Jun 30, 2020 | Baxter Healthcare Corporation | Devices | Baxter is updating the device IFU for safety communication regarding cleaning practices. |
| Jun 30, 2020 | CareFusion 303, Inc. | Devices | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit… |
| Jun 30, 2020 | CareFusion 303, Inc. | Devices | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit… |
| Jun 30, 2020 | CareFusion 303, Inc. | Devices | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit… |
| Jun 30, 2020 | CareFusion 303, Inc. | Devices | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit… |
| Jun 30, 2020 | CareFusion 303, Inc. | Devices | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit… |
| Jun 30, 2020 | CareFusion 303, Inc. | Devices | Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is… |
| Jun 30, 2020 | CareFusion 303, Inc. | Devices | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit… |
| Jun 30, 2020 | CareFusion 303, Inc. | Devices | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit… |
| Jun 30, 2020 | CareFusion 303, Inc. | Devices | If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on… |
| Jun 30, 2020 | CareFusion 303, Inc. | Devices | If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on… |
| Jun 30, 2020 | CareFusion 303, Inc. | Devices | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit… |
| Jun 29, 2020 | Transliquid Technologies, LLC | Drugs | Chemical Contamination: Presence of Undeclared Methanol |
| Jun 26, 2020 | Smiths Medical ASD Inc. | Devices | Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs. |
| Jun 26, 2020 | Smiths Medical ASD Inc. | Devices | Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs. |
| Jun 25, 2020 | HKH JVC LLC. | Food | Potential Listeria monocytogenes contamination. |
| Jun 24, 2020 | Beyond Better Foods Llc | Food | Product may contain undeclared milk. Chocolate Peanut Butter ice cream may be filled in pint sized Dairy-Free Chocolate Peanut Butter… |
| Jun 24, 2020 | Medichem S.A. | Drugs | Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches |
| Jun 23, 2020 | CareFusion 213, LLC | Drugs | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides |
| Jun 23, 2020 | CareFusion 213, LLC | Drugs | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides |
| Jun 23, 2020 | CareFusion 213, LLC | Drugs | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides |
| Jun 23, 2020 | Itech 361 LLC | Drugs | Chemical Contamination: Product contains undeclared methanol. |
| Jun 22, 2020 | UVT INC | Drugs | Chemical Contamination: Product contains undeclared methanol. |
| Jun 19, 2020 | Mount Franklin Foods LLC | Food | Potential to contain undeclared peanuts |
| Jun 18, 2020 | Fresh Express Incorpated | Food | The firm learned that, during a single production run, incorrect condiment packets were placed into Southwest Chopped Kit bags and, as a… |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical Contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | MICHIGAN HERBAL REMEDIES | Drugs | Chemical contamination: product contains elevated levels of undeclared lead. |
| Jun 18, 2020 | Trident Seafoods Corporation | Food | Product may contain undeclared egg white. |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
| Jun 16, 2020 | CME America, LLC | Devices | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the… |
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See one company's full record with the free FDA compliance check, or search warning letters and Form 483 citations by name.