876885
PLD Acquisitions LLC — FEI 2000009210
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 23, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 2402 | 21 CFR 211.194(a)(5) | Testing Calculations |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |