Sterling Pharmaceutical Services, LLC
Form 483 issued May 1, 2024 · East Carondelet, Illinois
- Inspection
- Apr 15 – May 1, 2024
- Investigators
- Jose E. Melendez· Mary L. Schuckmann
- Observations
- 8
- Pages
- 23
- FEI number
- 3009705561
In short: On May 1, 2024, FDA issued a Form 483 with 8 observations to Sterling Pharmaceutical Services, LLC in East Carondelet, Illinois (FEI 3009705561) after an inspection that ran Apr 15 – May 1, 2024. The investigators were Jose E. Melendez and Mary L. Schuckmann. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 5 of 8 observations.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sterling Pharmaceutical Services, LLC?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Sterling Pharmaceutical Services, LLC?
Jose E. Melendez and Mary L. Schuckmann are named on this Form 483, for the inspection of Apr 15 – May 1, 2024. Each investigator has a profile showing what they cite most.
When was Sterling Pharmaceutical Services, LLC inspected by FDA?
The inspection ran Apr 15 – May 1, 2024, and the Form 483 is dated May 1, 2024.
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.