FDA Inspection 1200247 — Immacule Lifesciences Private Limited
The FDA completed an inspection of Immacule Lifesciences Private Limited on Mar 14, 2023 in Nalagarh. 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
- Mar 14, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Nalagarh (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |