Laura Martin
CEO
Turbare Manufacturing
925 Jeanette Drive
Conway , AR 72032-6651
United StatesFEI 3027507354Issued Sep 16, 2025Center for Drug Evaluation and Research (CDER)
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 3027507354.
Violations5
Issue DateSep 16, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
Turbare Manufacturing
Location
Laura Martin
CEO
Turbare Manufacturing
925 Jeanette Drive
Conway , AR 72032-6651
United States
FEI Number
3027507354
Country
United States
Issue Date
September 16, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Turbare Manufacturing, an outsourcing facility registered to compound sterile drugs, was cited for serious deficiencies in its sterile drug manufacturing practices that put patients at risk during an FDA inspection conducted January 14-24, 2025. The facility produced Bevacizumab products that violated the Federal Food, Drug, and Cosmetic Act due to lack of sterility assurance, prompting the company to voluntarily recall two lots in February 2025. The FDA found that Turbare Manufacturing's compounding practices failed to meet the conditions required for outsourcing facilities to qualify for drug approval exemptions under section 503B of the FDCA.
Turbare Manufacturing FDA Warning Letter, September 16, 2025