FDA Inspection 1054619 — Selder S.A. de C.V.
The FDA completed an inspection of Selder S.A. de C.V. on June 1, 2018 in Ciudad De Mexico. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 1, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ciudad De Mexico (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |