FDA Inspection
Microtrol Sterilisation Services Pvt. Ltd.Microtrol Sterilisation Services Pvt. Ltd. – FDA Inspection, Jun 11, 2025
Record Details
This FDA Inspection record concerns Microtrol Sterilisation Services Pvt. Ltd., with an inspection on June 11, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- June 11, 2025
- Product Type
- Human Drugs
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ID · 10ada231-a918-442e-9889-c5113548083c
Inspection Facts
- Inspection number
- 1273614
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(b)Backup data not assured as exact and complete
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Other FDA inspections of Microtrol Sterilisation Services Pvt. Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 26, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Microtrol Sterilisation Services Pvt. Ltd.
- FDA Inspection 1045673 - 2018-03-21
- FDA Inspection 805148 - 2012-10-26
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