Jerome Stevens Pharmaceuticals, Inc.
FDA inspection history in Bohemia, New York, 2002 to 2022
- 2
- Form 483s
- 2
- Warning letters
Every document, by year
- Form 483
- Warning letter
2002: one warning letter; 2008: one warning letter; 2019: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2002One warning letter, at Bohemia, New York.
- 2008One warning letter, at Bohemia, New York.
- 2019One Form 483, at Bohemia, New York.
- 2022One Form 483, at Bohemia, New York.
- 2022The longest 483 on file: 7 observations over 9 pages at Bohemia, New York.
Cited most
Across all Jerome Stevens Pharmaceuticals observations on file
- 21 CFR 314.80(b)Postmarketing reporting of adverse drug experiences4
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.101(d)Charge-in of components1
- 21 CFR 211.110(c)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.142(b)Warehousing procedures1
The complete Jerome Stevens Pharmaceuticals file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Bohemia, New York
Two Form 483s and two warning letters · 2002 to 2022 · 11 observations
Latest: Form 483, Jun 15, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-06-15 | 483 Form 483 | Bohemia, New York | 7 | $99 |
| 2019-04-11 | 483 Form 483 | Bohemia, New York | 4 | $99 |
| 2008-10-23 | Warning letter Warning letter | Bohemia, New York | — | $99 |
| 2002-10-11 | Warning letter Warning letter | Bohemia, New York | — | $99 |
Investigators on these documents
Bijoy Panicker (1)Brandy N. Lepage (1)Karen L. Kosar (1)Omadevi Somai (1)
FEI number 2431950 · most recent document Jun 15, 2022
About Jerome Stevens Pharmaceuticals, Inc.
How many FDA Form 483s has Jerome Stevens Pharmaceuticals, Inc. received?
FDA Intel has 2 Form 483s on file for Jerome Stevens Pharmaceuticals, Inc.; the most recent is dated Jun 15, 2022.
When was Jerome Stevens Pharmaceuticals, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Jerome Stevens Pharmaceuticals, Inc. is a Form 483 dated Jun 15, 2022, for the site in Bohemia, New York.
What did FDA cite at Jerome Stevens Pharmaceuticals, Inc.?
The regulations cited most in the observations on file for Jerome Stevens Pharmaceuticals, Inc. are 21 CFR 314.80(b) (Postmarketing reporting of adverse drug experiences), 4 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.101(d) (Charge-in of components), 1 time.
Has Jerome Stevens Pharmaceuticals, Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Jerome Stevens Pharmaceuticals, Inc.; the most recent is dated Oct 23, 2008.