FDA Inspection 769290 — Topiderm Inc.
The FDA completed an inspection of Topiderm Inc. on February 24, 2012 in Amityville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 24, 2012
- Fiscal Year
- 2012
- 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 |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 15706 | 21 CFR 111.325(a) | Laboratory operations: electronic |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4344 | 21 CFR 211.160(b)(1) | Sampling and testing procedures described |