FDA Inspection 883147 — A&Z Pharmaceutical Inc
The FDA completed an inspection of A&Z Pharmaceutical Inc on June 3, 2014 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
- June 3, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 3548 | 21 CFR 211.46(c) | Air filtration system lacking in production area |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |