FDA Inspection 1220486 — Master Paints & Chemical Corp
The FDA completed an inspection of Master Paints & Chemical Corp on October 17, 2023 in Guayanilla, PR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 17, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Guayanilla, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |