Fagron Compounding Services LLC dba Fagron Sterile Services
Form 483 issued March 24, 2022 · Wichita, Kansas
- Inspection
- Mar 1 – Mar 24, 2022
- Investigators
- Alan M. Barker· Anthony Ladner
- Observations
- 6
- Pages
- 7
- FEI number
- 3012104093
In short: On March 24, 2022, 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 Mar 1 – Mar 24, 2022. The investigators were Alan M. Barker and Anthony Ladner. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Written procedm·es are not established that describe the in-process controls and examinations to be conducted on…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Alan M. Barker
10 documents · 2021–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Michigan.
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 211.42(c)(10)(v)
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 production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Fagron Compounding Services LLC dba Fagron Sterile Services?
Alan M. Barker and Anthony Ladner are named on this Form 483, for the inspection of Mar 1 – Mar 24, 2022. 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 Mar 1 – Mar 24, 2022, and the Form 483 is dated March 24, 2022.
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.