Drugs

CGMP Deviations Found in Polydrug Labs Inspection

A 3/16-23/15 FDA inspection at Polydrug Laboratories, Mumbai, India, found significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients. A 4/14 Warning Letter says that specific deviations included:

failing to record and investigate all quality-related customer complaints according to an established procedure;
failing to review and investigate all production deviations;
failing to ensure that computerized systems have sufficient controls to prevent unauthorized access or changes to data; and
failing to have appropriate test procedures to ensure that active pharmaceutical ingredients conform to established standards of quality and/or purity.

The letter says that the firm’s quality system “does not securely and reliably retain your manufacturing data and records.” It recommends that the company engage a third-party consultant with appropriate CGMP expertise to assess its facilities, procedures, processes, systems, and data integrity to ensure the identity, strength, quality, and purity of the active pharmaceutical ingredients it manufactures.

FDA says the firm’s responses to the observations were inadequate. It requests specific items in response to each observation and also requests:

a comprehensive investigation into the extent of the inaccuracies in data, records, and reporting;
a current risk assessment of the potential effects of the observed failures on the quality of the company’s drugs, including an analysis of the risks to patients caused by the release of drugs affected by a lapse of data integrity and risks posed by ongoing operations; and
a management strategy for the company including details of a global corrective action and preventive action plan.

Due to the inspection findings, the letter says, FDA placed the company on import alert on 9/11/15. If the company fails to correct the deviations, it says, the agency may continue to refuse admission to the U.S. of articles manufactured at the company plant. Polydrug Laboratories was told to respond with a list of specific steps taken to correct the deviations and prevent their recurrence and a timetable for completion.

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