Sterling Pharmaceutical Services, LLC
Form 483 issued February 18, 2022 · East Carondelet, Illinois
- Inspection
- Feb 7 – Feb 18, 2022
- Investigators
- Michael C. Zubelewicz· Wayne D. McGrath
- Observations
- 4
- Pages
- 6
- FEI number
- 3009705561
In short: On February 18, 2022, FDA issued a Form 483 with 4 observations to Sterling Pharmaceutical Services, LLC in East Carondelet, Illinois (FEI 3009705561) after an inspection that ran Feb 7 – Feb 18, 2022. The investigators were Michael C. Zubelewicz and Wayne D. McGrath. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 4 of 4 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Michael C. Zubelewicz
3 documents · 2022–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmSterling Pharmaceutical Services, LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sterling Pharmaceutical Services, LLC?
FDA listed 4 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Sterling Pharmaceutical Services, LLC?
Michael C. Zubelewicz and Wayne D. McGrath are named on this Form 483, for the inspection of Feb 7 – Feb 18, 2022. Each investigator has a profile showing what they cite most.
When was Sterling Pharmaceutical Services, LLC inspected by FDA?
The inspection ran Feb 7 – Feb 18, 2022, and the Form 483 is dated February 18, 2022.
How do I get the full Form 483 for Sterling Pharmaceutical Services, LLC?
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.