FDA Inspection 754338 — CMIC CMO USA Corporation
The FDA completed an inspection of CMIC CMO USA Corporation on Nov 30, 2011 in Cranbury, 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 30, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cranbury, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |