FDA Inspection 1037677 — Bimeda Pomona Inc.
The FDA completed an inspection of Bimeda Pomona Inc. on Jan 11, 2018 in Pomona, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 22 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 11, 2018
- Fiscal Year
- 2018
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Pomona, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 21295 | 21 CFR 211.110(b) | In-process conformity - examination, sample testing |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |