FDA Inspection
Prescript Pharmaceuticals, Inc.Prescript Pharmaceuticals, Inc. – FDA Inspection, Mar 30, 2018
Record Details
This FDA Inspection record concerns Prescript Pharmaceuticals, Inc., with an inspection on March 30, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9dc5cce7-8d37-4c91-a7ce-0c42c8da835f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046277
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Prescript Pharmaceuticals, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 7, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 25, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 16, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 3, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 21, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Prescript Pharmaceuticals, Inc.
- FDA Inspection 1269790 - 2025-05-07
- FDA Inspection 873762 - 2014-03-25
- FDA Inspection 752730 - 2011-11-16
- FDA Inspection 711361 - 2011-03-03
- FDA Inspection 598180 - 2009-07-21
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