Drugs

CGMP Violations, Import Alert at Badrivishal Chemicals

An 8/16-8/19/16 FDA inspection at Badrivishal Chemicals & Pharmaceuticals, Maharashtra, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients, according to a 3/2 Warning Letter. Specific deviations cited in the letter included:

failure to validate and monitor the water purification system to ensure that water is of appropriate quality and suitable for its intended use;
failure of the firm’s quality unit to prepare, review, and approve documents relating to the manufacturing of active pharmaceutical ingredients;
failure to verify the suitability of analytical methods; and
failure to adequately investigate critical deviations.

“Based upon the nature and pervasiveness of the deviations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations to assist your firm in meeting CGMP requirements,” the letter says. It notes that Badrivishal has a contract quality assurance agreement with an unidentified firm to test its products. It reminds Badrivishal that it is responsible for the quality of the drugs it produces, regardless of any agreements with a contract testing laboratory.

The firm’s responses to the inspection observations were inadequate. It was told to submit a comprehensive investigation into the extent of inaccuracies in data records and reporting; a current risk assessment of the potential effects of the observed failures on the quality of its drugs; and a management strategy the includes details of a global corrective action and preventive action plan.

The firm was placed on an import alert 12/19/16. Badrivishal was told to respond with specific actions taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion.

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