FDA Inspection 1119240 — Cyan Labs, S.A. de C.V.
The FDA completed an inspection of Cyan Labs, S.A. de C.V. on February 28, 2020 in Ciudad Apodaca. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 28, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ciudad Apodaca (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |