FDA Inspection 1042488 — BioDiagnostic International
The FDA completed an inspection of BioDiagnostic International on February 27, 2018 in Brea, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 27, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brea, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |