FDA Inspection 784829 — Vils Pharma Coating, LLC
The FDA completed an inspection of Vils Pharma Coating, LLC on June 1, 2012 in Edison, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 1, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |