FDA Inspection
Enem Nostrum Remedies Pvt. Ltd.Enem Nostrum Remedies Pvt. Ltd. – FDA Inspection, Apr 11, 2017
Record Details
This FDA Inspection record concerns Enem Nostrum Remedies Pvt. Ltd., with an inspection on April 11, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6abfac34-d0f3-4e2e-87f0-048881d33405
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017544
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Enem Nostrum Remedies Pvt. Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 24, 2025 | Not classified | Office of Inspections and Investigations | |
| April 11, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 29, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Enem Nostrum Remedies Pvt. Ltd.
- FDA Inspection 1290282 - 2025-09-24
- FDA Inspection 1052189 - 2018-04-11
- FDA Inspection 848764 - 2013-08-29
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