Warning letter
Accu Bio-Chem Laboratories: warning letter of Feb 24, 2022
FDA warning letter 619450 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 619450 |
|---|---|
| Company | Accu Bio-Chem Laboratories |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Feb 24, 2022 |
| Posted date | Mar 15, 2022 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.192, 211.68(b), 211.165(e) |
| Inspection city | Glendale |
| Inspection ZIP | 91201 |
| Inspection start date | Aug 24, 2021 |
| 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: