SterRx
FDA inspection history across 3 sites, 2017 to 2023
- 3
- Form 483s
- 2
- Warning letters
Every document, by year
- Form 483
- Warning letter
2017: one Form 483; 2018: one warning letter; 2021: one Form 483; 2022: one warning letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–18One Form 483 and one warning letter, at Plattsburgh, New York and New York.
- 2021–23Two Form 483s and one warning letter, at Plattsburgh, New York and Schaumburg, Illinois.
- 2021The longest 483 on file: 12 observations over 26 pages at Plattsburgh, New York.
Cited most
Across all SterRx observations on file
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.28(a)Personnel responsibilities2
- 21 CFR 211.63Equipment design, size, and location2
The complete SterRx file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Plattsburgh, New York
Three Form 483s · 2017 to 2023 · 24 observations
Latest: Form 483, Jun 28, 2023 →Schaumburg, Illinois
One warning letter · 2022
Latest: Warning letter, Jul 27, 2022 →New York
One warning letter · 2018
Latest: Warning letter, Oct 17, 2018 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-06-28 | 483 Form 483 | Plattsburgh, New York | 7 | $99 |
| 2022-07-27 | Warning letter Warning letter | Schaumburg, Illinois | — | $99 |
| 2021-11-04 | 483 Form 483 | Plattsburgh, New York | 12 | $99 |
| 2018-10-17 | Warning letter Warning letter | New York | — | $99 |
| 2017-03-17 | 483 Form 483 | Plattsburgh, New York | 5 | $99 |
Investigators on these documents
Edmund F. Mrak (2)Chad N. Thompson (1)Lori M. Newman (1)Pushpa S. Jayasekara (1)Rachael Moliver (1)
FEI number 3010840309 · most recent document Jun 28, 2023
About SterRx
How many FDA Form 483s has SterRx received?
FDA Intel has 3 Form 483s on file for SterRx; the most recent is dated Jun 28, 2023.
When was SterRx last inspected by FDA?
The most recent FDA inspection document on file for SterRx is a Form 483 dated Jun 28, 2023, for the site in Plattsburgh, New York.
What did FDA cite at SterRx?
The regulations cited most in the observations on file for SterRx are 21 CFR 211.42 (Design and construction features), 5 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.166 (Stability testing), 2 times.
Has SterRx received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for SterRx; the most recent is dated Jul 27, 2022.