FDA Inspection 1066603 — Berlimed, S.A.
The FDA completed an inspection of Berlimed, S.A. on September 25, 2018 in Alcala de Henares. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 25, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Alcala de Henares (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |