FDA Inspection 1100953 — Cohance Lifesciences Limited
The FDA completed an inspection of Cohance Lifesciences Limited on Aug 20, 2019 in Medchal-Malkajgiri. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 20, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Medchal-Malkajgiri (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |