FDA Inspection 710120 — DermaRite Industries, LLC
The FDA completed an inspection of DermaRite Industries, LLC on Mar 3, 2011 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
- Mar 3, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- North Bergen, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |