Drugs

CGMP Violations Found in 2 Lupin Facilities

A 3/27-4/7 FDA inspection at the Lupin Limited drug manufacturing facility in Goa, India, and a 5/8-5/19 inspection at the facility in Indore, Madhya, Pradesh, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at each plant, according to an 11/6 Warning Letter. Specific violations for both the Goa and Indore facility 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 appropriate time limits for completing each phase of production to assure the quality of the drug product.

The letter says that both facilities were cited 3/11/16 for invalidating out-of-specification (OOS) results without thorough investigations, among other things. “These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” it says. “You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements at all your sites.”

The agency strongly recommends that the firm retain a qualified consultant to assist it in meeting CGMP requirements. In particular, it says, the consultant should comprehensively assess the firm’s manufacturing processes and laboratory systems, and retrospectively review all OOS investigations.

Lupin was told to respond with a list of steps taken since the inspections to correct the violations and prevent their recurrence, with a timetable for completion.

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