FDA Inspection 821739 — Fareva Pau
The FDA completed an inspection of Fareva Pau on Feb 26, 2013 in Idron. 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
- Feb 26, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Idron (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3581 | 21 CFR 211.101(d) | Verification of component addition |