FDA Inspection
Microtrol Sterilisation Services Pvt. Ltd.Microtrol Sterilisation Services Pvt. Ltd. – FDA Inspection, Mar 21, 2018
Record Details
This FDA Inspection record concerns Microtrol Sterilisation Services Pvt. Ltd., with an inspection on March 21, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c8ee27f5-2d5e-4fe3-b4f3-c7e2aac1627a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1045673
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.182Specific information required in individual logs
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Microtrol Sterilisation Services Pvt. Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 11, 2025 | Not classified | Office of Inspections and Investigations | 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 1273614 - 2025-06-11
- FDA Inspection 805148 - 2012-10-26
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