Warning letter
Sure-Biochem Laboratories, LLC: warning letter of Mar 24, 2023
FDA warning letter 646619 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 646619 |
|---|---|
| Company | Sure-Biochem Laboratories, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Mar 24, 2023 |
| Posted date | May 23, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 211.194(a), 211.160(a), 211.34, 820, 211.22(a) |
| Inspection city | Camden |
| Inspection ZIP | 08104 |
| Inspection start date | Sep 28, 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: