Sterling Pharmaceutical Services, LLC
FDA inspection history across 2 sites, 2018 to 2024
- 4
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2018: one Form 483; 2021: one Form 483; 2022: one warning letter and one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at East Carondelet, Illinois.
- 2021–24Three Form 483s and one warning letter, at East Carondelet, Illinois and Dupo, Illinois.
- 2024The longest 483 on file: 8 observations over 23 pages at East Carondelet, Illinois.
Cited most
Across all Sterling Pharmaceutical Services observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.192Production record review4
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.100Written procedures; deviations1
The complete Sterling Pharmaceutical Services 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
East Carondelet, Illinois
Four Form 483s · 2018 to 2024 · 21 observations
Latest: Form 483, May 1, 2024 →Dupo, Illinois
One warning letter · 2022
Latest: Warning letter, Sep 27, 2022 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-01 | 483 Form 483 | East Carondelet, Illinois | 8 | $99 |
| 2022-09-27 | Warning letter Warning letter | Dupo, Illinois | — | $99 |
| 2022-02-18 | 483 Form 483 | East Carondelet, Illinois | 4 | $99 |
| 2021-05-14 | 483 Form 483 | East Carondelet, Illinois | 4 | $99 |
| 2018-04-06 | 483 Form 483 | East Carondelet, Illinois | 5 | $99 |
Investigators on these documents
Robert J. Ham (2)Jose E. Melendez (1)Lisa R. Hilliard (1)Gretchen L. Trendel (1)Michael C. Zubelewicz (1)Wayne D. McGrath (1)Mary L. Schuckmann (1)
FEI number 3009705561 · most recent document May 1, 2024
About Sterling Pharmaceutical Services, LLC
How many FDA Form 483s has Sterling Pharmaceutical Services, LLC received?
FDA Intel has 4 Form 483s on file for Sterling Pharmaceutical Services, LLC; the most recent is dated May 1, 2024.
When was Sterling Pharmaceutical Services, LLC last inspected by FDA?
The most recent FDA inspection document on file for Sterling Pharmaceutical Services, LLC is a Form 483 dated May 1, 2024, for the site in East Carondelet, Illinois.
What did FDA cite at Sterling Pharmaceutical Services, LLC?
The regulations cited most in the observations on file for Sterling Pharmaceutical Services, LLC are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.42 (Design and construction features), 4 times.
Has Sterling Pharmaceutical Services, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Sterling Pharmaceutical Services, LLC; the most recent is dated Sep 27, 2022.