Warning letter
ByHeart, Inc.: warning letter of Aug 30, 2023
FDA warning letter 653854 · HUMAN AND ANIMAL FOOD WEST I COMPLIANCE BRANCH (HAFW1-CB)
Key facts
| Reference number | 653854 |
|---|---|
| Company | ByHeart, Inc. |
| Subject | CGMP/Quality Control/Adulterated/Infant Formula |
| Issue date | Aug 30, 2023 |
| Posted date | Aug 30, 2023 |
| Issuing office | HUMAN AND ANIMAL FOOD WEST I COMPLIANCE BRANCH (HAFW1-CB) |
| Product type | Food/Cosmetics |
| CFR sections cited | 106.150, 106, 106.55(a) |
| Inspection city | Reading |
| Inspection ZIP | 19606 |
| Inspection start date | Dec 21, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: