FDA Inspection 1218129 — Ultra Seal Corporation
The FDA completed an inspection of Ultra Seal Corporation on Sep 20, 2023 in New Paltz, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 20, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- New Paltz, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |