FDA Inspection
Enaltec Labs Private LimitedEnaltec Labs Private Limited – FDA Inspection, Jul 26, 2019
Record Details
This FDA Inspection record concerns Enaltec Labs Private Limited, with an inspection on July 26, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fc304e96-1e82-4c7d-8738-4077ea5adf58
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100340
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Enaltec Labs Private Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 27, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| November 10, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 8, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Enaltec Labs Private Limited
- FDA Inspection 1265451 - 2025-03-27
- FDA Inspection 948708 - 2015-11-10
- FDA Inspection 846593 - 2013-08-08
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