FDA Inspection 994491 — Cosco International, Inc.
The FDA completed an inspection of Cosco International, Inc. on Nov 29, 2016 in Marietta, GA. 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). 12 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 29, 2016
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Marietta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |