FDA WARNING_LETTER - Jagsonpal Pharmaceuticals Limited - April 03, 2024

On February 5, 2025, the FDA issued a Warning Letter to Jagsonpal Pharmaceuticals Limited following an inspection from March 20 to April 3, 2024, at their Bhiwadi Dist., Alwar, Rajasthan facility. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs), rendering their API adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include the failure of Jagsonpal's quality unit to ensure CGMP compliance at their contract manufacturing organization (CMO), (b)(4). Jagsonpal, despite being listed as the manufacturer and supervising the CMO, did not ensure adequate process validation, complete master production instructions, or proper verification of compendial analytical methods. The FDA considers contractors as extensions of the manufacturer, holding Jagsonpal responsible for drug quality.

Additionally, the FDA was initially refused entry on March 15, 2024, and subsequently faced limited access to requested documents (e.g., analytical data, equipment logbooks, change control) during the inspection, which can deem drugs adulterated under section 501(j) of the FD&C Act.

Furthermore, significant establishment registration and drug listing violations were identified. The CMO, (b)(4), is not registered with the FDA, and the drug (b)(4) was not listed by