FDA Inspection 1034103 — A&Z Pharmaceutical Inc
The FDA completed an inspection of A&Z Pharmaceutical Inc on November 22, 2017 in Hauppauge, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 22, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2086 | 21 CFR 211.208 | Salvaging and return to marketplace |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |