FDA Inspection
Strides Pharma, Inc.Strides Pharma, Inc. – FDA Inspection, Aug 7, 2009
Record Details
This FDA Inspection record concerns Strides Pharma, Inc., with an inspection on August 7, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Strides Pharma, Inc.
- Inspection Date
- August 7, 2009
- Product Type
- Drugs
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ID · 6eb05a86-2c81-4134-a89d-d1ce3836bb8b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 603167
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.192Investigations of discrepancies, failures
- 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 |
| June 5, 2019 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| March 16, 2017 | 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 1092153 - 2019-06-05
- FDA Inspection 1009619 - 2017-03-16
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