FDA Inspection
Prescript Pharmaceuticals, Inc.Prescript Pharmaceuticals, Inc. – FDA Inspection, Nov 16, 2011
Record Details
This FDA Inspection record concerns Prescript Pharmaceuticals, Inc., with an inspection on November 16, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 16, 2011
- Product Type
- Drugs
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ID · 84f15e45-5eae-49e6-b720-3782e2e58d6a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 752730
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.170(b)Drug product reserve containers
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.166(a)Lack of written stability program
- 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 30, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 25, 2014 | 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 1046277 - 2018-03-30
- FDA Inspection 873762 - 2014-03-25
- FDA Inspection 711361 - 2011-03-03
- FDA Inspection 598180 - 2009-07-21
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