Fagron Compounding Services LLC dba Fagron Sterile Services
Form 483 issued June 28, 2024 · Wichita, Kansas
- Inspection
- Jun 18 – Jun 28, 2024
- Investigator
- Taichun Qin
- Observations
- 7
- Pages
- 11
- FEI number
- 3012104093
In short: On June 28, 2024, FDA issued a Form 483 with 7 observations to Fagron Compounding Services LLC dba Fagron Sterile Services in Wichita, Kansas (FEI 3012104093) after an inspection that ran Jun 18 – Jun 28, 2024. The investigator was Taichun Qin. Most observations concern quality system and packaging & labeling.
At a glance
Quality system and packaging & labeling account for 5 of 7 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
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 04
Complaint records are deficient in that they do not include the findings of…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
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
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 7 observations on this Form 483, mostly about quality system, packaging & labeling and production. The opening words of each observation are shown on this page.
Who inspected Fagron Compounding Services LLC dba Fagron Sterile Services?
Taichun Qin is named on this Form 483, for the inspection of Jun 18 – Jun 28, 2024. 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 Jun 18 – Jun 28, 2024, and the Form 483 is dated June 28, 2024.
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.