Large Number of Deficiencies at Indian Manufacturer results in Warning Letter

In January 2024, the FDA inspected Eugia Pharma Specialities Limited in Hyderabad and identified several significant deficiencies, resulting in a Warning Letter on August 20, 2024, after the company’s responses to Form 483 were deemed inadequate.

Key issues included:

1. Incomplete Laboratory Documentation: The company failed to accurately document test data, compromising data integrity, and manipulated environmental monitoring data.

2. Inadequate Cleaning Documentation: Records for cleaning and sterilization were inaccurate, with employees documenting activities they did not perform. The response lacked details on how video surveillance would support quality assurance.

3. Failures in Aseptic Procedures: Written procedures to prevent contamination were insufficient, and employees often did not adhere to aseptic practices, increasing contamination risks.

4. Insufficient Investigation of Deviations: The company failed to conduct thorough investigations of production deviations, particularly with vial breakages.

The FDA mandates a comprehensive review of the CAPA program and regular audits to ensure product quality and safety.