FDA blocks imports from two Indian API makers over manufacturing violations

The FDA has issued warning letters to two India-based manufacturers of active pharmaceutical ingredients — Jagsonpal Pharmaceuticals Limited and Tyche Industries Ltd — citing significant violations of current Good Manufacturing Practices (cGMP) that resulted in their products being deemed adulterated under the Federal Food, Drug, and Cosmetic Act. 

The warning letters, issued respectively on Feb. 5 and 6, 2025, detail serious compliance failures including quality control lapses, data integrity issues, as well as the failure to ensure proper registration with the FDA.

Jagsonpal Pharmaceuticals, based in Rajasthan, was found to have inadequate oversight of its contract manufacturing operations. The FDA’s inspection revealed that the company failed to ensure that its contract manufacturing organization (CMO) adhered to cGMP standards. Additionally, the company did not properly validate its manufacturing processes or verify that analytical methods used for drug testing were suitable for their intended use.

The FDA also cited Jagsonpal for obstructing its inspection process by initially refusing entry to inspectors and later limiting access to requested documents. The agency placed the company’s products on Import Alert 66-40, effectively blocking them from entering the U.S. market.

Tyche Industries, located in Andhra Pradesh, was similarly flagged for cGMP violations, including falsification of manufacturing data. The FDA’s inspection revealed that company employees had manipulated temperature records for a drying oven used in drug production, leading to failures in product quality.

Additionally, Tyche was cited for poor documentation practices, inadequate equipment cleaning procedures that posed risks of cross-contamination, and failing to properly test incoming raw materials for identity verification. The agency also placed Tyche’s products on Import Alert 66-40, barring them from U.S. importation.

Both companies were ordered to provide detailed corrective action plans addressing the deficiencies identified in their facilities. The FDA specifically recommended that Jagsonpal conduct a comprehensive review of its quality oversight systems and confirm that its contract manufacturer is properly registered.

Tyche was directed to overhaul its data integrity controls, conduct an independent review of its cleaning and maintenance procedures, and reassess the adequacy of its raw material testing processes. The agency warned that failure to correct these issues could result in continued import bans and the withholding of new drug application approvals.

These enforcement actions underscore the FDA’s heightened scrutiny of foreign pharmaceutical manufacturers supplying the U.S. market. The agency has ramped up its inspections and regulatory interventions in recent years to ensure compliance with cGMP standards and protect public health. Companies found to be in violation face significant consequences, including restrictions on market access and potential legal action.

Jagsonpal and Tyche now have 15 working days to respond to the FDA with their proposed corrective actions. If the companies fail to adequately address the violations, they risk further regulatory enforcement, including the possibility of additional penalties or prolonged import restrictions.