FDA 483 - Ocean Healthcare Pvt Ltd - June 14, 2024

During an inspection conducted from June 10-14, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Ocean Healthcare Pvt Ltd, a pharmaceutical manufacturer located in Chengalpattu District, Tamil Nadu, India. This document highlighted significant observations concerning the firm's compliance with regulatory standards.

Key issues identified included inadequate written procedures for handling customer complaints. Specifically, an investigation into a complaint regarding 'cloudy' capsules (MC/23/008) was based on customer-provided photos rather than physical samples, and lacked scientific evidence to support potential causes. Additionally, the company failed to perform essential growth promotion tests on each lot of in-house prepared culture media before its use in microbiological assays, indicating a gap in quality control for critical components. Furthermore, the quality control unit's responsibilities and procedures were not fully documented or consistently followed. Verbal policies concerning practices like trial injection and manual integration during HPLC and GC analyses were not incorporated into the relevant standard operating procedures, which is vital for data integrity and consistent operational practices.

These observations indicate deviations from current good manufacturing practices. Ocean Healthcare Pvt Ltd is expected to address these findings by developing and implementing comprehensive corrective and preventive actions to ensure full compliance with FDA regulations.