Drugs

CGMP Violations at Lupin Limited

A 3/22-4/4 FDA inspection at the Lupin Limited drug manufacturing facility in Maharashtra, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 9/27 Warning Letter says the specific deviations were:

failing to establish adequate written procedures for cleaning equipment and its release for use in manufacturing intermediates and APIs;
failing to establish written procedures to monitor the progress and control the performance of processing steps that may cause variability in the quality characteristics of intermediates and APIs;
failing to investigate all critical deviations.

FDA says Lupin’s response to the form FDA-483 was inadequate because it did not provide sufficient detail or evidence of corrective actions to bring the company’s operation into compliance with CGMP.

The letter acknowledges Lupin’s commitment to suspend the production of drugs for the U.S. market and says if the company plans to resume manufacturing drugs for the U.S. market it should notify FDA before resuming operations.

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

Gupta Raises Concerns About Overton’s Independence, Ideology

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome