FDA Inspection
Jerome Stevens Pharmaceuticals, Inc.Jerome Stevens Pharmaceuticals, Inc. – FDA Inspection, May 6, 2009
Record Details
This FDA Inspection record concerns Jerome Stevens Pharmaceuticals, Inc., with an inspection on May 6, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 6, 2009
- Product Type
- Drugs
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ID · 28876756-e6a2-4cc1-bab2-80d12a665976
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 580444
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
22- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.84(c)(2)Containers sampled so as to prevent contamination
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(b)Backup file not maintained
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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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