Sterling Pharmaceutical Services, LLC
Form 483 issued May 14, 2021 · East Carondelet, Illinois
- Inspection
- May 3 – May 14, 2021
- Investigators
- Gretchen L. Trendel· Lisa R. Hilliard· Robert J. Ham
- Observations
- 4
- Pages
- 7
- FEI number
- 3009705561
In short: On May 14, 2021, FDA issued a Form 483 with 4 observations to Sterling Pharmaceutical Services, LLC in East Carondelet, Illinois (FEI 3009705561) after an inspection that ran May 3 – May 14, 2021. The investigators were Gretchen L. Trendel, Lisa R. Hilliard and Robert J. Ham. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
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 are not…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Gretchen L. Trendel
6 documents · 2021–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kansas.
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 quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Sterling Pharmaceutical Services, LLC?
Gretchen L. Trendel, Lisa R. Hilliard and Robert J. Ham are named on this Form 483, for the inspection of May 3 – May 14, 2021. Each investigator has a profile showing what they cite most.
When was Sterling Pharmaceutical Services, LLC inspected by FDA?
The inspection ran May 3 – May 14, 2021, and the Form 483 is dated May 14, 2021.
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.