FDA cites Lupin for lax oversight of equipment breakdowns, poor follow up and more
The US Food and Drug Administration (FDA) chastised India-based Lupin in a recent untitled letter for a multitude of good manufacturing practice (GMP) violations, including lax investigations into equipment failures and poor complaint follow-up.The facility produces solid oral dosage forms, inhalation products, dermatology products, highly potent products and oral contraceptives.
The report went to Amit Sareen, site head and senior vice president for manufacturing at its Pithampur site and follows a mid-March inspection this year.
FDA cited the firm for ten violations; one was a failure to adequately investigate equipment breakdowns. The firm recorded 1,695 breakdown notifications from January 2019 to March 2023, yet only investigated 41.
The firm also failed to support the integrity of data in the computer system that was affected by computer breakdowns. The untitled letter noted that, “you recorded 16 breakdown notifications where manufacturing data was not captured in the data acquisition software for some manufacturing and packaging equipment during batch operations for US marketed products.” Yet the firm only investigated one breakdown.
The company also failed to investigate the origin of an empty capsule that was found by an inspector during a visual inspection on 20 October 2020. The investigation revealed the empty capsule was supplied by a vendor that adhered to differing specifications from other batches. Yet the firm did not submit a field alert report (FAR) to FDA and supplied the batches of the affected product to the US market anyway.
FDA also cited the firm for failing to investigate complaints and conduct a follow-up of complaints. FDA said “you recorded at least 40 complaints for short count/underfilled [products] and for different products from 2019 to date. You have not taken any appropriate actions to prevent recurrence, although you concluded they did not happen at your facility through deficient investigation.”
FDA investigators said employees also lacked the necessary training required to perform their assigned functions. “Training is assigned in SABA software …. and you do not assign the due dates in SABA.” It said that personnel assigned to training are “currently overdue.” In addition, the firm failed to provide ongoing GMP train to contracted personnel.
This is not the first time Lupin has encountered problems with FDA with respect to its manufacturing practices.
In October 2022, the company was slapped with a warning letter for issues with the company’s written procedures for equipment cleaning, its written procedures for monitoring and controlling performance of processing steps and the “failure to investigate all critical deviations.” (RELATED: FDA sends warning letter to Lupin, Amazon and Walmart, Regulatory Focus, 1 November 2022).
In June 2021, a Lupin subsidiary in New Jersey received a warning letter for cleaning violations and inadequate process controls. (RELATED: FDA warns Lupin subsidiary, aesthetic firm, Regulatory Focus, 29 June 2021).
In June 2028, the company received an untitled letter stemming from problems related to investigating batch failures.
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