Fagron Compounding Services LLC dba Fagron Sterile Services
Form 483 issued September 21, 2016 · Wichita, Kansas
- Inspection
- Aug 29 – Sep 21, 2016
- Investigator
- Brett R. Havranek
- Observations
- 4
- Pages
- 3
- FEI number
- 3012104093
In short: On September 21, 2016, FDA issued a Form 483 with 4 observations to Fagron Compounding Services LLC dba Fagron Sterile Services in Wichita, Kansas (FEI 3012104093) after an inspection that ran Aug 29 – Sep 21, 2016. The investigator was Brett R. Havranek. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has…
- 03
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Brett R. Havranek
6 documents · 2015–2018
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Kansas.
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 211.165(a)
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 4 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Fagron Compounding Services LLC dba Fagron Sterile Services?
Brett R. Havranek is named on this Form 483, for the inspection of Aug 29 – Sep 21, 2016. 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 Aug 29 – Sep 21, 2016, and the Form 483 is dated September 21, 2016.
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.