FDA Inspection 720401 — Cosway Company, Inc.
The FDA completed an inspection of Cosway Company, Inc. on April 8, 2011 in Carson, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 8, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carson, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1957 | 21 CFR 211.180(e)(2) | Review of problem drugs |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |