Jerome Stevens Pharmaceuticals, Inc.
Form 483 issued April 11, 2019 · Bohemia, New York
- Investigators
- Karen L. Kosar· Omadevi Somai
- Observations
- 4
- Pages
- 4
- FEI number
- 2431950
In short: On April 11, 2019, FDA issued a Form 483 with 4 observations to Jerome Stevens Pharmaceuticals, Inc. in Bohemia, New York (FEI 2431950). The investigators were Karen L. Kosar and Omadevi Somai. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observation- 01
Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of…
- 02
You failed to submit a periodic report containing an analysis of the post marketing 15-day Alert…
- 03
Periodic reports of non-alert adverse drug experiences have not been submitted yearly for an application which…
- 04
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA…
This inspection in context
Karen L. Kosar
4 documents · 2013–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New York.
The firmJerome Stevens Pharmaceuticals, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 314.80(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jerome Stevens Pharmaceuticals, Inc.?
FDA listed 4 observations on this Form 483. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
Who inspected Jerome Stevens Pharmaceuticals, Inc.?
Karen L. Kosar and Omadevi Somai are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Jerome Stevens Pharmaceuticals, Inc. inspected by FDA?
This Form 483 is dated April 11, 2019.
How do I get the full Form 483 for Jerome Stevens Pharmaceuticals, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.