FDA Inspection
Steriscience Specialties Private LimitedSteriscience Specialties Private Limited – FDA Inspection, Mar 28, 2024
Record Details
This FDA Inspection record concerns Steriscience Specialties Private Limited, with an inspection on March 28, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 03e50cb3-e408-46ef-8877-e110752321ab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1234275
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.192No written record of investigation
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.165(f)Failing drug products not rejected
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Other FDA inspections of Steriscience Specialties Private Limited
7| Date | Classification | Office | Project area |
|---|---|---|---|
| December 20, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 16, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 8, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 12, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Steriscience Specialties Private Limited
- FDA Inspection 1114642 - 2019-12-20
- FDA Inspection 1044193 - 2018-03-13
- FDA Inspection 963420 - 2016-03-16
- FDA Inspection 890880 - 2014-08-08
- FDA Inspection 847764 - 2013-08-12
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