Warning Letter to Indian API Manufacturer because of Restricted Access
इंस्टीट्यूट ऑफ गुड मैन्यूफैक्चरिंग प्रैक्टिसेज इंडिया
Institute of Good Manufacturing Practices India

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Warning Letter to Indian API Manufacturer because of Restricted Access

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