Drugs

FDA Hits Lupin with Warning on 2 Indian Facilities

FDA is continuing to take Indian drug manufacturers to task over compliance with agency regulations. The latest sees FDA issuing a combined Warning Letter to India-based Lupin after two drug manufacturing facilities at Goa and Indore were inspected earlier this year and investigators documented significant GMP violations.

At Goa, a three-item Form 483 said the firm failed to thoroughly review any unexplained discrepancy and the failure of a batch to meet any of its specifications. The company also invalidated numerous out-of-specification results by retesting and reporting the average results of replicate tests. FDA also cited Lupin for not having appropriate written procedures for production and process controls. And it said control procedures are not established to monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

Meanwhile at Indore, a six-observation Form 483 said the firm dismissed 96% of all the out-of-specification results obtained during testing of commercial drug products during the last two years — 76% of these attributed to human error, which FDA says raises concerns about employees’ ability to conduct analytical testing. They also cited it for inadequate written records of investigations because they do not include conclusions and follow-up. Additionally, the agency said there are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality and purity they purport to possess.

For its part, Lupin says it has already responded to all inspection observations. It further says no supply disruption is expected at either facility. However, the company says “there will likely be a delay of new product approvals from these two facilities.”

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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