FDA Inspection 1077046 — MEDGEL PRIVATE LIMITED
The FDA completed an inspection of MEDGEL PRIVATE LIMITED on Jan 25, 2019 in Pithampur, Dhar. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 25, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pithampur, Dhar (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |