FDA Inspection 1261268 — Medical Chemical Corporation
The FDA completed an inspection of Medical Chemical Corporation on February 18, 2025 in Torrance, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 18, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Torrance, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |