FDA Inspection
Strides Pharma, Inc.Strides Pharma, Inc. – FDA Inspection, Jun 5, 2019
Record Details
This FDA Inspection record concerns Strides Pharma, Inc., with an inspection on June 5, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · bee39198-9be0-43fc-8690-27a98db749e1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1092153
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Strides Pharma, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| December 23, 2025 | Not classified | New York District Office | |
| February 8, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 23, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 16, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 4, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Strides Pharma, Inc.
- FDA Inspection 1292202 - 2025-12-23
- FDA Inspection 1162483 - 2022-02-08
- FDA Inspection 1103039 - 2019-08-23
- FDA Inspection 1009619 - 2017-03-16
- FDA Inspection 932525 - 2015-06-04
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