FDA Inspection 1119240 — Cyan Labs, S.A. De C.V.
The FDA completed an inspection of Cyan Labs, S.A. De C.V. on Feb 28, 2020 in Ciudad Apodaca. 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
- Feb 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 |