FDA Inspection 938255 — Topiderm Inc.
The FDA completed an inspection of Topiderm Inc. on June 15, 2015 in Amityville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 15, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Amityville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2005 | 21 CFR 211.184(e) | Records of disposition of rejected material |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4309 | 21 CFR 211.84(c)(2) | Containers sampled so as to prevent contamination |
| 4405 | 21 CFR 211.194(a)(2) | Statement of methods and data |