FDA Inspection 677224 — Ultra Seal Corporation
The FDA completed an inspection of Ultra Seal Corporation on Aug 3, 2010 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 3, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- New Paltz, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1637 | 21 CFR 211.130(e) | Packaging line inspection after use |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |