FDA inspection
Enaltec Labs Private Limited: FDA inspection ending Mar 27, 2025
FDA inspection 1265451 · Voluntary Action Indicated (VAI) · Kalyan
Key facts
| Inspection ID | 1265451 |
|---|---|
| Firm | Enaltec Labs Private Limited |
| FEI number | 3006599894 |
| Address | Additional Ambernath Midc Plot No N - 61 Anand Nagar, Ambernath East |
| City | Kalyan |
| Country | India |
| Fiscal year | 2025 |
| Inspection end date | Mar 27, 2025 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data