Drugs

Violations at Sovereign Pharmaceuticals

A 4/13-4/22 FDA inspection at Sovereign Pharmaceuticals, Fort Worth, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other violations. A 10/5 Warning Letter says specific violations were:

failing to establish adequate written procedures for production and process controls designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess, and the failure of the firm’s quality control unit to review and approve the procedures, including any changes;
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 had already been distributed; and
failing to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit.

FDA strongly recommends the firm engage a qualified consultant to assist it in meeting CGMP requirements.

The letter also says the agency determined that Sovereign is distributing a biological product without FDA approval or a valid biologics license.

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

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