FDA Inspection 989528 — Cosco Enterprises, Inc
The FDA completed an inspection of Cosco Enterprises, Inc on Oct 27, 2016 in Ridgewood, NY. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 27, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ridgewood, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |