US FDA hits Intas Pharma with warning letter; notes data integrity lapses at Ahmedabad plant

The US FDA instructed the executive management to immediately and comprehensively assess company’s global manufacturing operations to ensure that its systems, processes, and products conform to FDA requirements

The United States Food and Drug Administration (US FDA) has noted violations in data integrity and good manufacturing practices at Intas Pharmaceutical’s plant in Ahmedabad in its latest warning letter to the company.

According to the letter dated 21 November, the company’s “quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.”

The regulator said that since 2021, visual inspectors manipulated particle and other defect counts on manual visual inspection records in many instances, to keep the finished product batches within rejection limits. The investigation found that operators manipulated the defect quantities “to keep the category-wise rejections within limits to avoid a deviation and investigation.

Intas Pharmaceuticals Limited had said in June 2023 that its manufacturing facility near Ahmedabad has been listed under ‘Import Alert’ by the US Food and Drug Administration (USFDA), however, it had received permission to ship 24 critical products in short supply in the US after completion of necessary testing and verification.

Intas had responded to the warning letter issued by the company earlier in the year. The US FDA, however, stated in the recent warning letter that many of its responses were inadequate and has instructed further corrective action.

The letter also noted that Intas failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products. The report notes lapses in smoke studies in the plant.

The regulator noted that in a previous inspection, including the inspection of July 22 to August 02, 2019, FDA cited similar CGMP observations. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” it said.

In addition to the lack of effective production and laboratory operations oversight, the regulator said that it found Intas’ quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities.

The US FDA instructed the executive management to immediately and comprehensively assess the company’s global manufacturing operations to ensure that its systems, processes, and products conform to FDA requirements.

Intas Pharma was incorporated in 1985 and is the flagship company of the Ahmedabad-based Chudgar Group. The company operates in chronic therapeutic segments, including neurology and psychiatry. Over the years, the company diversified into wide therapeutic areas and ventured into international markets through exports of generic drugs and contract manufacturing.

Communications to the company for a response on the matter remained unanswered.