FDA Inspection 1267554 — Betco Corporation, Ltd
The FDA completed an inspection of Betco Corporation, Ltd on April 17, 2025 in Bowling Green, OH. 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
- April 17, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bowling Green, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |