FDA Inspection 678362 — Medical Chemical Corporation
The FDA completed an inspection of Medical Chemical Corporation on August 31, 2010 in Torrance, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 31, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Torrance, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4330 | 21 CFR 211.130(e) | Packaging line inspection documentation |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 537 | 21 CFR 820.70(a) | Production processes |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |