FDA Inspection
Jerome Stevens Pharmaceuticals, Inc.Jerome Stevens Pharmaceuticals, Inc. – FDA Inspection, Apr 11, 2019
Record Details
This FDA Inspection record concerns Jerome Stevens Pharmaceuticals, Inc., with an inspection on April 11, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e9416f67-016c-4214-a419-65df4af479cd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086248
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Interval
- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report
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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 |
| 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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