FDA 483 - Indoco Remedies Limited - July 16, 2024

An FDA inspection of Indoco Remedies Limited, a sterile and non-sterile drug manufacturer located in Vasco Da Gama, Goa, India, was conducted from July 16 to July 26, 2024. The inspection revealed multiple significant deviations from current Good Manufacturing Practices (cGMP) regulations. Key issues included deficient procedures for investigating consumer complaints, such as missing labels and container integrity problems, with the firm reportedly invalidating complaints without agency notification. Aseptic process validation was inadequate, highlighted by flawed smoke studies and incorrect personnel monitoring standards in critical areas (a repeat observation). The Quality Control unit also demonstrated deficiencies, including a failure to routinely review critical warning messages in laboratory software and poor sample accountability. Furthermore, control procedures to prevent microbiological contamination of sterile drugs were found to be insufficient (another repeat observation), citing issues like obstructed airflow in sterile environments, facility maintenance concerns (leaks in air handling units), and inadequate environmental monitoring for cleanroom garment washers. These observations necessitate a comprehensive corrective and preventive action plan to address the identified non-conformances.