FDA Inspection 955350 — ACS Dobfar S.p.A.
The FDA completed an inspection of ACS Dobfar S.p.A. on January 19, 2016 in Teramo, San Nicolo A Tordino. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 19, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Teramo, San Nicolo A Tordino (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2402 | 21 CFR 211.194(a)(5) | Testing Calculations |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4403 | 21 CFR 211.194(b) | Test method modification records do not include |