FDA 483 - Apex Healthcare Limited - June 15, 2023

An FDA inspection of Apex Healthcare Limited in Ankleshwar, Gujarat, India, conducted from June 12 to June 15, 2023, identified significant deficiencies in the company's quality management and control systems. The inspection resulted in three observations requiring immediate attention.

Firstly, the firm's procedure for reviewing laboratory control records, specifically its audit trail process for HPLC and GC chromatographic systems, was deemed inadequate. The existing procedure did not mandate the review and assessment of error messages within the System Activity Logs after each analytical sequence, despite a recent internal risk assessment highlighting various communication and analysis aborted errors. This oversight could compromise data integrity and the reliability of analytical results.

Secondly, computerized systems at Apex Healthcare lacked sufficient controls to prevent data loss. It was observed that the System Activity Log of a specific Agilent HPLC instrument (HPLC 01) automatically overwrote older data, retaining only information dating back to August 2021. This practice risks the permanent loss of critical historical data related to the testing of numerous finished API lots manufactured and tested prior to that date.

Finally, the inspection revealed the absence of an established procedure for label reconciliation. The company did not record the number of labels printed, used, and returned during the labeling of finished Active Pharmaceutical Ingredients. This lack of accountability creates a potential vulnerability for mislabeling or unauthorized use of product labels.

These findings indicate a need for Apex Healthcare to implement robust corrective and preventive actions to enhance data integrity, ensure comprehensive record-keeping, and establish stricter control over critical manufacturing processes to meet regulatory expectations.