Cipla faces USFDA scrutiny over manufacturing lapses in Pithampur plant

The US Food and Drug Administration (USFDA) has raised concerns over manufacturing practices at Cipla's facility in Pithampur, Madhya Pradesh. In a letter addressed to Cipla's Managing Director, Umang Vohra, the USFDA outlined significant violations of Current Good Manufacturing Practice (CGMP) regulations observed during an inspection conducted from February 6 to 17, 2023.

According to the USFDA, Cipla's methods, facilities, and controls for manufacturing, processing, packing, or holding do not align with CGMP standards, leading to the classification of drug products as adulterated. The letter specifically pointed out lapses in thoroughly investigating unexplained discrepancies or failures in batches, whether distributed or not.

Additionally, the USFDA highlighted Cipla's failure to establish and follow written procedures aimed at preventing microbiological contamination of drug products purporting to be sterile. This includes the validation of aseptic and sterilisation processes. The regulatory body also noted deficiencies in establishing adequate written responsibilities and procedures for the quality control unit.

The USFDA emphasised that similar CGMP observations had been cited at other facilities operated by Cipla in the past. The letter called on Cipla's executive management to promptly address all deficiencies and conduct a comprehensive assessment of the company's global manufacturing operations to ensure alignment with FDA requirements.

The USFDA warned that failure to rectify the identified violations may result in the FDA refusing admission of articles manufactured at the Pithampur plant, located in the Indore Special Economic Zone.

(With PTI Inputs)