FDA Inspection 1182260 — Broncolin, S.A. De C.V.
The FDA completed an inspection of Broncolin, S.A. De C.V. on Oct 28, 2022 in Ciudad De Mexico. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 28, 2022
- Fiscal Year
- 2023
- 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 |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4345 | 21 CFR 211.160(b)(1) | Samples (various types) representative, identified properly |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |