Jerome Stevens Pharmaceuticals, Inc.
Form 483 issued June 15, 2022 · Bohemia, New York
- Inspection
- May 25 – Jun 15, 2022
- Investigators
- Bijoy Panicker· Brandy N. Lepage
- Observations
- 7
- Pages
- 9
- FEI number
- 2431950
In short: On June 15, 2022, FDA issued a Form 483 with 7 observations to Jerome Stevens Pharmaceuticals, Inc. in Bohemia, New York (FEI 2431950) after an inspection that ran May 25 – Jun 15, 2022. The investigators were Bijoy Panicker and Brandy N. Lepage. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 02
Verification of the suitability of the testing methods is deficient in that they are not documented…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
In-process materials are not tested for and approved or rejected by…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) 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 211.67(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 7 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Jerome Stevens Pharmaceuticals, Inc.?
Bijoy Panicker and Brandy N. Lepage are named on this Form 483, for the inspection of May 25 – Jun 15, 2022. Each investigator has a profile showing what they cite most.
When was Jerome Stevens Pharmaceuticals, Inc. inspected by FDA?
The inspection ran May 25 – Jun 15, 2022, and the Form 483 is dated June 15, 2022.
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.