FDA Inspection 1238041 — Berioska SL
The FDA completed an inspection of Berioska SL on May 3, 2024 in Cheste. 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
- May 3, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cheste (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4576 | 21 CFR 211.192 | No written record of investigation |