FDA Inspection 983913 — Coating Systems Laboratories, Inc
The FDA completed an inspection of Coating Systems Laboratories, Inc on Aug 2, 2016 in Chandler, AZ. 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
- Aug 2, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chandler, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |