MiMedx Group, Inc.
1 extracted findings
FDA source excerpt, selected passage
Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity [21 CFR 211.160(b)].** Specifically, your firm has not established laboratory controls that include appropriate final specifications for testing and release of AXIOFILL™ to assure that each batch conforms to appropriate standards of identity and purity during routine production.
Findings and supporting evidence
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Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.