FDA Inspection 1234325 — MMC HEALTHCARE LTD.
The FDA completed an inspection of MMC HEALTHCARE LTD. on March 30, 2024 in Chennai. 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
- March 30, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chennai (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |