FDA Inspection 1068193 — Topiderm Inc.
The FDA completed an inspection of Topiderm Inc. on October 9, 2018 in Amityville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 9, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Amityville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |