FDA Inspection 1066757 — Bell-More Labs, Inc.
The FDA completed an inspection of Bell-More Labs, Inc. on September 26, 2018 in Hampstead, MD. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 26, 2018
- Fiscal Year
- 2018
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Hampstead, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |