FDA Inspection
Sindan-Pharma SRLSindan-Pharma SRL – FDA Inspection, Jul 28, 2017
Record Details
This FDA Inspection record concerns Sindan-Pharma SRL, with an inspection on July 28, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 28d85fc2-099b-45cc-8a29-8c6beb1e56ca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019456
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.46(c)Exhaust systems inadequate to control air contamination
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(b)Procedures for sterile drug products
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Other FDA inspections of Sindan-Pharma SRL
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 16, 2023 | Not classified | Office of Inspections and Investigations | |
| April 5, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 15, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 10, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sindan-Pharma SRL
- FDA Inspection 1247794 - 2024-08-02
- FDA Inspection 1244074 - 2023-03-16
- FDA Inspection 1137635 - 2018-04-05
- FDA Inspection 933708 - 2015-06-15
- FDA Inspection 874880 - 2013-12-10
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