Drugs

CGMP Violations in Omeza Inspection

A 7/24-7/28/2023 FDA inspection at the Omeza drug manufacturing facility in Sarasota, FL, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 12/12/2023 Warning Letter says specific violations were:

failing to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition, and keeping them free of infestation by rodents, birds, insects, and other vermin;
failing to conduct at least one test to verify the identity of each component of a drug product and failing to validate and establish the reliability of the component supplier’s test analyses at appropriate intervals; and
failing to follow a written testing program to assess the stability characteristics of drug products and to use the results of stability testing to determine appropriate storage conditions and expiration dates.

The letter says the company’s responses to the inspection findings were inadequate.

FDA also discusses unapproved new drug violations for two of the company’s over-the-counter products and misbranded drug violations. It recommends that Omeza engage a qualified consultant to assist it in meeting CGMP requirements.

Omeza was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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