FDA Inspection
Steriscience Specialties Private LimitedSteriscience Specialties Private Limited – FDA Inspection, Nov 22, 2024
Record Details
This FDA Inspection record concerns Steriscience Specialties Private Limited, with an inspection on November 22, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- November 22, 2024
- Product Type
- Human Drugs
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ID · 8476992a-3ffa-4cb5-a082-ad476e6d9d59
Inspection Facts
- Inspection number
- 1256494
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Steriscience Specialties Private Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 14, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 1, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 3, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Steriscience Specialties Private Limited
- FDA Inspection 1079813 - 2019-02-14
- FDA Inspection 940034 - 2015-09-01
- FDA Inspection 712230 - 2011-02-03
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