India-based active pharmaceutical ingredient makers Jagsonpal Pharmaceuticals and Tyche Industries have each received warning letters from the US Food and Drug Administration.
Both companies were also placed on the FDA’s import alert list following the regulator’s findings, effectively barring their products from entering the American market.
Jagsonpal Pharmaceuticals, headquartered in Gurugram near New Delhi, was inspected between March and April 2024, with inspectors uncovering serious concerns about the origin of its products.
The FDA found that Jagsonpal had used a third-party contract manufacturer to produce active pharmaceutical ingredients, which the company then claimed as its own on import records.
Inspectors were initially refused entry to the Jagsonpal facility on March 15, 2024, a significant violation that compounded the agency’s concerns about the company’s transparency.
The FDA was eventually granted access on March 20, but inspectors reported receiving only limited access to documents they had formally requested during the visit.
Jagsonpal was further criticised for failing to properly register its own products, as well as those produced on its behalf by the third-party manufacturer, with the FDA.
The agency moved to place Jagsonpal’s products on import alert on January 17, ahead of the formal warning letter being made public.
Tyche Industries, whose manufacturing plant is located in Kakinada, received its warning letter on February 6 following an inspection conducted last August at that facility.
The company had previously received and responded to an FDA Form 483 connected to the same inspection, but the regulator concluded that Tyche’s response was insufficient.
Central to the FDA’s concerns about Tyche was the performance of its quality control unit, which the agency accused of failing to ensure the integrity of manufacturing process records at the facility.
The FDA’s inspection revealed that Tyche employees had manipulated temperature records for a drying oven used in drug production, leading to failures in product quality.
Tyche was also 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 placed Tyche’s products on Import Alert 66-40, barring them from the US market pending satisfactory resolution of the identified violations.