FDA Inspection 869230 — Bieffe Medital, S.A.
The FDA completed an inspection of Bieffe Medital, S.A. on Feb 23, 2014 in Sabinanigo. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 23, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sabinanigo (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1174 | 21 CFR 211.42(b) | Product flow through building is inadequate |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |