FDA Inspection 755069 — Ultra Seal Corporation
The FDA completed an inspection of Ultra Seal Corporation on November 15, 2011 in New Paltz, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 15, 2011
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- New Paltz, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |