FDA Inspection 921048 — Dermaceutical Laboratories, LLC
The FDA completed an inspection of Dermaceutical Laboratories, LLC on Apr 6, 2015 in Teterboro, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 6, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Teterboro, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 3548 | 21 CFR 211.46(c) | Air filtration system lacking in production area |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4386 | 21 CFR 211.198(b) | Written complaint record to be maintained at facility |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |