Fagron Compounding Services LLC dba Fagron Sterile Services
Form 483 issued June 21, 2019 · Wichita, Kansas
- Inspection
- Jun 10 – Jun 21, 2019
- Investigator
- Erika V. Butler
- Observations
- 11
- Pages
- 8
- FEI number
- 3012104093
In short: On June 21, 2019, FDA issued a Form 483 with 11 observations to Fagron Compounding Services LLC dba Fagron Sterile Services in Wichita, Kansas (FEI 3012104093) after an inspection that ran Jun 10 – Jun 21, 2019. The investigator was Erika V. Butler. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent that would alter…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Protective apparel is not worn as necessary to protect…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Erika V. Butler
23 documents · 2007–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
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 211.67(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 11 observations on this Form 483, mostly about quality system, facilities & equipment and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Fagron Compounding Services LLC dba Fagron Sterile Services?
Erika V. Butler is named on this Form 483, for the inspection of Jun 10 – Jun 21, 2019. 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 10 – Jun 21, 2019, and the Form 483 is dated June 21, 2019.
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.