USFDA issues warning letter to Lupin for Maharashtra-based API plant

The US health regulator has pulled up drug maker Lupin for manufacturing lapses, including failure to establish adequate written procedures for cleaning equipment, at its Maharashtra-based plant.

In a warning letter, the US Food and Drug Administration (USFDA) has pointed out various lapses at the Tarapur (Thane) plant which produces active pharmaceutical ingredients (API).

"This warning letter summarises significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API)," the US health regulator said.

It further said: "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API is adulterated..."

The USFDA inspected the manufacturing facility from March 22 to April 4, 2022.

A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.

In the warning letter the health regulator pointed out the company's "failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture of intermediates and API".

It also pointed out failure on the part of the plant management 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 API.

The USFDA also said the plant administration failed to investigate all critical deviations.

"We acknowledge your commitment to suspend production of drugs for the US market. In response to this letter, clarify whether you intend to resume manufacturing any drugs at this facility in the future," it said.

If the company plans to resume manufacturing drugs for the US market, notify this office before resuming operations, it said.

"FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations," USFDA said.

It further stated: "The warning letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence."

The warning letter issued by the USFDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.

The letter also makes clear that the company must correct the problem and provides directions and a timeframe of its plans for correction.

FDA then checks to ensure that the company's corrections are adequate.