Sterling Pharmaceutical Services, LLC
Form 483 issued April 6, 2018 · East Carondelet, Illinois
- Inspection
- Mar 22 – Apr 6, 2018
- Investigator
- Robert J. Ham
- Observations
- 5
- Pages
- 5
- FEI number
- 3009705561
In short: On April 6, 2018, FDA issued a Form 483 with 5 observations to Sterling Pharmaceutical Services, LLC in East Carondelet, Illinois (FEI 3009705561) after an inspection that ran Mar 22 – Apr 6, 2018. The investigator was Robert J. Ham. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 03
Procedures describing the handling of written and oral complaints related to drug products are…
- 04
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
This inspection in context
Robert J. Ham
32 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Missouri.
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sterling Pharmaceutical Services, LLC?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Sterling Pharmaceutical Services, LLC?
Robert J. Ham is named on this Form 483, for the inspection of Mar 22 – Apr 6, 2018. Each investigator has a profile showing what they cite most.
When was Sterling Pharmaceutical Services, LLC inspected by FDA?
The inspection ran Mar 22 – Apr 6, 2018, and the Form 483 is dated April 6, 2018.
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.