FDA Inspection 1037369 — CMIC CMO USA Corporation
The FDA completed an inspection of CMIC CMO USA Corporation on Jan 11, 2018 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 11, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cranbury, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |