FDA Inspection
Stason Pharmaceuticals, Inc.Stason Pharmaceuticals, Inc. – FDA Inspection, Jun 14, 2017
Record Details
This FDA Inspection record concerns Stason Pharmaceuticals, Inc., with an inspection on June 14, 2017, issued by the Los Angeles District Office, covering human drugs.
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ID · d2a11582-e18d-41de-a719-3f0cd642e3f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014137
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)(1)Specification description of sample/testing
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Stason Pharmaceuticals, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 25, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 24, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 8, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 22, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Stason Pharmaceuticals, Inc.
- FDA Inspection 1140029 - 2021-04-13
- FDA Inspection 1109969 - 2019-10-25
- FDA Inspection 1067952 - 2018-08-24
- FDA Inspection 960658 - 2016-03-08
- FDA Inspection 911418 - 2015-01-22
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