FDA Inspection 777346 — ACS Dobfar S.P.A.
The FDA completed an inspection of ACS Dobfar S.P.A. on Mar 27, 2012 in Teramo, San Nicolo A Tordino. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 27, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Teramo, San Nicolo A Tordino (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3546 | 21 CFR 211.46(a) | Adequate ventilation not provided |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4404 | 21 CFR 211.194(a)(1) | Sample identification and other information |