FDA Inspection
Jerome Stevens Pharmaceuticals, Inc.Jerome Stevens Pharmaceuticals, Inc. – FDA Inspection, Jun 15, 2022
Record Details
This FDA Inspection record concerns Jerome Stevens Pharmaceuticals, Inc., with an inspection on June 15, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 15, 2022
- Product Type
- Drugs
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ID · 67813e87-ce22-451a-81c7-80581be0452e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1171967
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.101(d)Component release checked by 2nd person
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.194(a)(2)Laboratory Test Method Verification
- 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 |
| 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 |
| November 21, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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