Drugs

CGMP Violations at India’s Shilpa Medicare Limited

A 2/2-2/25 FDA inspection at the Shilpa Medicare Limited drug production facility in Telangana, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/9 Warning Letter says specific violations were:

failing to thoroughly investigate any unexplained discrepancy or failure of a batch of any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
failing to follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product including the review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation.

The letter also cites field reporting violations since the firm received several complaints in 2017 and 2018 related to extrinsic particles observed in vials of several batches of an injectable and no field alert report was submitted to FDA.

“We are concerned with the CGMP violations demonstrated at your facility and failure to submit field alert reporting-related events within three days of becoming aware of the problem,” the letter says. “Please include in your written response the corrective action you plan to take regarding distributed products manufactured at your facility that may be affected by the violations.”

FDA recommends that the firm engage a qualified consultant to assist it in meeting CGMP requirements.

Shilpa was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the actions.

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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