FDA Inspection 1113237 — Bel Star S.A.
The FDA completed an inspection of Bel Star S.A. on Dec 13, 2019 in Tocancipa. 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
- Dec 13, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tocancipa (Colombia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |