FDA Inspection 1181457 — Makson Health Care Private Ltd.
The FDA completed an inspection of Makson Health Care Private Ltd. on Sep 29, 2022 in Annaram. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 29, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Annaram (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |