MiMedx receives FDA warning letter over Axiofill manufacturing concerns

The FDA has high­light­ed de­vi­a­tions from cur­rent good man­u­fac­tur­ing prac­tice for MiMedx’s Ax­iofill, a pla­cen­ta-based prod­uct which is un­der re­view re­gard­ing its le­gal clas­si­fi­ca­tion.

Af­ter a man­u­fac­tur­ing in­spec­tion, MiMedx re­ceived a warn­ing let­ter on Dec. 21 that was post­ed on Tues­day, in which the FDA said the com­pa­ny failed to put in place writ­ten pro­ce­dures for pro­duc­tion and process con­trol and lacked sound lab con­trols to en­sure prod­uct iden­ti­ty, strength, qual­i­ty and pu­ri­ty.

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