FDA Inspection 1116566 — ULTRAtab Laboratories, Inc.
The FDA completed an inspection of ULTRAtab Laboratories, Inc. on January 31, 2020 in Highland, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 31, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Highland, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |