FDA Inspection 843815 — ULTRAtab Laboratories, Inc.
The FDA completed an inspection of ULTRAtab Laboratories, Inc. on Aug 2, 2013 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 2, 2013
- Fiscal Year
- 2013
- 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 |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |