FDA Inspection 548089 — DermaRite Industries, LLC
The FDA completed an inspection of DermaRite Industries, LLC on Nov 17, 2008 in North Bergen, 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 17, 2008
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- North Bergen, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |