Fagron Compounding Services LLC dba Fagron Sterile Services
Form 483 issued August 8, 2025 · Wichita, Kansas
- Inspection
- Jul 29 – Aug 8, 2025
- Investigator
- Sean R. Marcsisin
- Observations
- 6
- Pages
- 10
- FEI number
- 3012104093
In short: On August 8, 2025, FDA issued a Form 483 with 6 observations to Fagron Compounding Services LLC dba Fagron Sterile Services in Wichita, Kansas (FEI 3012104093) after an inspection that ran Jul 29 – Aug 8, 2025. The investigator was Sean R. Marcsisin. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile are not…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
- 04
Tlie number of qualified personnel is inadequate to perform the manufacture…
This inspection in context
Sean R. Marcsisin
22 documents · 2016–2025
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Massachusetts.
The firmFagron Compounding Services LLC dba Fagron Sterile Services history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fagron Compounding Services LLC dba Fagron Sterile Services?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Fagron Compounding Services LLC dba Fagron Sterile Services?
Sean R. Marcsisin is named on this Form 483, for the inspection of Jul 29 – Aug 8, 2025. Each investigator has a profile showing what they cite most.
When was Fagron Compounding Services LLC dba Fagron Sterile Services inspected by FDA?
The inspection ran Jul 29 – Aug 8, 2025, and the Form 483 is dated August 8, 2025.
How do I get the full Form 483 for Fagron Compounding Services LLC dba Fagron Sterile Services?
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.