FDA Inspection 657372 — ULTRAtab Laboratories, Inc.
The FDA completed an inspection of ULTRAtab Laboratories, Inc. on May 5, 2010 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 5, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Highland, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |