Fagron Compounding Services, LLC dba Fagron Sterile Service

Warning LetterOpen

Jason McGuire Senior Vice President, Operations Fagron Compounding Services, LLC dba Fagron Sterile Service 8710 East 34th Street North Wichita , KS 67226-2636 United StatesFEI 3012104093Issued Dec 19, 2024Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012104093.

Violations5

Issue DateDec 19, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Fagron Compounding Services, LLC dba Fagron Sterile Service
Location: Jason McGuire Senior Vice President, Operations Fagron Compounding Services, LLC dba Fagron Sterile Service 8710 East 34th Street North Wichita , KS 67226-2636 United States
FEI Number: 3012104093
Country: United States
Issue Date: December 19, 2024
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Fagron Compounding Services, an outsourcing facility registered to produce sterile drug products, produced adulterated drugs that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act, thereby losing exemptions from standard drug approval requirements. During a June 2024 FDA inspection, investigators identified serious deficiencies in the facility's practices for producing sterile drug products that put patients at risk, including lack of sterility assurance in compounded medications. The company had already initiated a voluntary recall of four lots of Lidocaine HCl Injection, 2% in August 2024 due to sterility concerns, and submitted multiple responses to FDA's Form 483 observations between July and October 2024.

Fagron Compounding Services, LLC dba Fagron Sterile Service FDA Warning Letter, December 19, 2024