Warning letter
Ultra Seal Corporation: warning letter of Mar 14, 2022
FDA warning letter 624650 · Office of Pharmaceutical Quality Operations
Key facts
| Reference number | 624650 |
|---|---|
| Company | Ultra Seal Corporation |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Mar 14, 2022 |
| Posted date | Apr 12, 2022 |
| Issuing office | Office of Pharmaceutical Quality Operations |
| Product type | Drugs |
| CFR sections cited | 211.192, 211.22(a), 211.67(b), 211.68(b), 211.160(a) |
| Inspection city | New Paltz |
| Inspection ZIP | 12561 |
| Inspection start date | Nov 8, 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: