FDA Inspection 1112221 — Laboratorios Rety de Colombia SAS
The FDA completed an inspection of Laboratorios Rety de Colombia SAS on December 6, 2019 in Barranquilla. 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
- December 6, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Barranquilla (Colombia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |