FDA Inspection
Jerome Stevens Pharmaceuticals, Inc.Jerome Stevens Pharmaceuticals, Inc. – FDA Inspection, Mar 10, 2010
Record Details
This FDA Inspection record concerns Jerome Stevens Pharmaceuticals, Inc., with an inspection on March 10, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 10, 2010
- Product Type
- Drugs
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ID · c01877ee-2c6d-4697-aee0-ae9ec82cfdc2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 651032
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.111Deviations of production time limits
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.160(b)(2)In-process materials - sampling, testing procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| July 23, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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