INCELL Corporation LLC
FDA's Center for Biologics Evaluation and Research issued a Warning Letter to INCELL Corporation LLC (San Antonio, TX) on December 12, 2024, finding that its amniotic fluid-derived product is an unapproved new drug and unlicensed biological product under the FD&C Act and PHS Act. The company also committed multiple CGMP violations including failure to validate aseptic processes, lack of identity testing specifications, and unsupported expiration dating. The product's Instructions for Use were found to contain false or misleading labeling, rendering it misbranded, and FDA warned that failure to remediate may result in seizure and/or injunction.
Flagged claims (2)
Neither of these statements about the stability of your product are supported with stability data.
your labeling is false or misleading
Required actions (2)
We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence.
Failure to adequately address these matters may result in regulatory action without further notice. Such actions may include seizure and/or injunction.
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