FDA Inspection 1279930 — Bio-Medical Pharmaceutical Manufacturing Corporation
The FDA completed an inspection of Bio-Medical Pharmaceutical Manufacturing Corporation on August 29, 2025 in Houston, TX. 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
- August 29, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Houston, TX (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 |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1823 | 21 CFR 211.84(c)(4) | Top/Middle/Bottom container sampling |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2013 | 21 CFR 211.188(b)(1) | Significant Step Accomplishment Dates |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |