Drugs

CGMP Issues at India‘s Apotex Research Private

An 11/6-11/17/17 FDA inspection at the Apotex Research Private Limited drug manufacturing facility in Bangalore, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 8/9 Warning Letter. The specific violations cited in the letter 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; and
failing to establish valid in-process specifications.

The letter says the firm’s “inspectional history indicates that your quality unit does not fully exercise authority, such as ensuring that appropriate investigations are performed with sound conclusions, identifying root causes, and supporting scientific justification. Your firm must provide your quality unit with appropriate authority, sufficient resources, and staff to carry out its responsibilities and consistently ensure drug quality.”

The agency has cited similar CGMP violations and deviations at this and other facilities in the company’s network, the letter says. “FDA has previously communicated about the need for appropriate and global quality oversight to Apotex senior management during several regulatory meetings,” the letter says. “These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate.”

In light of the company’s failure to correct repeat violations, FDA says, it should engage a qualified consultant to assist it in meeting CGMP requirements and perform a comprehensive audit of its entire operation for CGMP compliance, evaluating the completion and effectiveness of any corrective and preventive actions that are implemented before pursuing resolution of the firm’s compliance status with FDA.

Apotex Research Private Limited was placed on an import alert 4/12.

The company was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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