FDA Inspection 779674 — Pierrel S.p.A.
The FDA completed an inspection of Pierrel S.p.A. on March 5, 2012 in Capua. 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
- March 5, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Capua (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1933 | 21 CFR 211.167(a) | Sterility/pyrogens - test methods written, followed |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |