Warning Letter to Indian API Manufacturer because of Restricted Access

During an FDA inspection of Jagsonpal Pharmaceuticals Limited in Gurugram, Haryana, India from 20 March to 3 April 2024, serious GMP violations were identified, leading to an import alert. Key deficiencies included:

1. Inadequate supervision of contract manufacturer: The company failed to oversee its Contract Manufacturing Organization (CMO), which resulted in unvalidated processes, incomplete master batch records, and improperly verified analytical methods.
2. Access restrictions during inspection: The FDA was denied access to the facility and essential documents, such as logbooks, change control forms, and analytical test data, which is a serious violation.
3. Violations of registration and listing requirements: One API was not properly registered with the FDA, and the company falsely claimed to be the manufacturer, while an unregistered CMO handled production.

The FDA has recommended a comprehensive quality system review and suggests hiring an independent GMP consultant.

25-04-2025