FDA Inspection
Jerome Stevens Pharmaceuticals, Inc.Jerome Stevens Pharmaceuticals, Inc. – FDA Inspection, Jul 23, 2015
Record Details
This FDA Inspection record concerns Jerome Stevens Pharmaceuticals, Inc., with an inspection on July 23, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 23, 2015
- Product Type
- Drugs
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ID · cb3f1624-3051-467b-8c29-27151e06a9e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 935880
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.111Deviations of production time limits
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Jerome Stevens Pharmaceuticals, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 15, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 11, 2019 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
| March 30, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 21, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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