FDA Inspection 737695 — ULTRAtab Laboratories, Inc.
The FDA completed an inspection of ULTRAtab Laboratories, Inc. on Aug 2, 2011 in Highland, 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 2, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Highland, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |