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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来源: EndPoints

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