FDA Inspection 1199737 — Debiopharm Research & Manufacturing S.A.
The FDA completed an inspection of Debiopharm Research & Manufacturing S.A. on March 14, 2023 in Martigny. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 14, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Martigny (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |