Warning letter
Bi-Coastal Pharma International: warning letter of Jun 30, 2022
FDA warning letter 628196 · Office of Pharmaceutical Quality Operations Division I
Key facts
| Reference number | 628196 |
|---|---|
| Company | Bi-Coastal Pharma International |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jun 30, 2022 |
| Posted date | Jul 26, 2022 |
| Issuing office | Office of Pharmaceutical Quality Operations Division I |
| Product type | Drugs |
| CFR sections cited | 211.198(a), 211.34, 211.192, 211.22(a), 211.25(b) |
| Inspection city | Shrewsbury |
| Inspection ZIP | 07702 |
| Inspection start date | Dec 15, 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: