FDA Inspection
Jerome Stevens Pharmaceuticals, Inc.Jerome Stevens Pharmaceuticals, Inc. – FDA Inspection, Nov 23, 2010
Record Details
This FDA Inspection record concerns Jerome Stevens Pharmaceuticals, Inc., with an inspection on November 23, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 23, 2010
- Product Type
- Drugs
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ID · 248b8a40-d653-4a6e-ba88-ebc73e0c127f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 699938
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
- 21 CFR 211.42(b)Product flow through building is inadequate
- 21 CFR 211.130(a)Prevention of cross contamination, mix-ups
- 21 CFR 211.67(b)Written procedures not established/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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