FDA Inspection 1223539 — Betone, S.A. de C.V.
The FDA completed an inspection of Betone, S.A. de C.V. on November 10, 2023 in Zapopan. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 10, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Zapopan (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1371 | 21 CFR 211.101(a) | Batches Formulated to less than 100% |
| 1384 | 21 CFR 211.101(c) | Weighing/measuring/subdividing supervision |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3633 | 21 CFR 211.170(b)(1) | Reserve sample retention time |