Drugs

CGMP, Other Violations Seen in Eosera Inspection

A 1/13-1/17 FDA inspection at Eosera, Inc., Fort Worth, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/13 Warning Letter says specific violations were:

failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
failing to follow a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates;
failure of the quality control unit to review and approve written procedures for production and process control, including any changes to them, designed to ensure that the drug products the firm manufactures have the identity, strength, quality, and/or purity they purport or are represented to possess; and
failing to establish an adequate quality control unit and procedures applicable to the quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

The letter also says the firm distributes several over-the-counter otic products that are considered to be unapproved new drugs. FDA says the Eosera products are not labeled or formulated following the otic final rule or the external analgesic tentative final monograph. It also says the firm’s quality systems are inadequate and recommends that Eosera engage a qualified consultant to assist it in meeting CGMP requirements.

Eosera was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the actions.

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