Overview

Omeza, LLC is a skin health company that develops a drug-device combination product called OCM™, designed to provide comprehensive therapy for all phases of wound healing.

Therapeutic areas

Wound CareDermatology

FDA compliance signals

9 FDA enforcement records linked to this company.

  • recall — Class II2024-02-14

    CGMP Deviations

  • recall — Class II2024-02-14

    CGMP Deviations

  • warning_letter2023-12-12

    FDA Warning Letter (drug product)

  • 4832023-07-28

    Written program not followed

  • 4832023-07-28

    Written procedures not established/followed

  • 4832023-07-28

    Sanitation--buildings not clean, free of infestation

  • 4832023-07-28

    Testing and release for distribution

  • 4832023-07-28

    Reports of Analysis (Components)

  • 4832023-07-28

    Complete instructions, procedures, specifications et. al.

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