Omeza warned over poor manufacturing conditions; MiMedx in FDA talks over Axiofill reclassification

Skin health com­pa­ny Omeza was is­sued an FDA warn­ing let­ter af­ter sev­er­al man­u­fac­tur­ing is­sues were un­cov­ered at its site in Sara­so­ta, FL. Mean­while, MiMedx is in dis­cus­sions with the agency on the po­ten­tial re­clas­si­fi­ca­tion of its pla­cen­tal-de­rived tis­sue prod­uct Ax­iofill.

The warn­ing let­ter to Omeza, post­ed on the FDA web­site on Dec. 26, was trig­gered by an in­spec­tion be­tween Ju­ly 24 and 28, with the com­pa­ny re­spond­ing on Aug. 17. How­ev­er, ac­cord­ing to the warn­ing let­ter dat­ed Dec. 12, the agency deemed the com­pa­ny’s re­sponse as “in­ad­e­quate.”

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