FDA 483_RESPONSE - Cosway Company, Inc. - October 27, 2023

Cosway Co. underwent an FDA inspection from October 25 to October 27, 2023, resulting in several observations documented in FDA Form 483. The inspection identified critical issues primarily related to data integrity and equipment monitoring within the company's operations.

The main violations included inadequate control over computer systems, specifically the use of an unvalidated Excel spreadsheet for storing stability data and generating reports for OTC drug products. This spreadsheet lacked essential security features like an audit trail, raising concerns about data integrity. Additionally, the report generation process allowed for the approval signature to precede the preparer’s signature, undermining procedural accuracy.

In response, Cosway Co. plans to implement a new Laboratory Information Management System (LIMS) with enhanced security features, including audit trails and password protections, by February 2024. The company is also revising its documentation protocols and training staff to ensure compliance with proper documentation practices.

Another significant issue was the failure to investigate out-of-specification (OOS) temperature and humidity readings in stability chambers. To address this, Cosway Co. will install a temperature/humidity alert system by January 2024 and has developed new Standard Operating Procedures (SOPs) for OOS investigations and preventative maintenance, with completion targeted for mid-November 2023.

These corrective actions are aligned with regulatory requirements to ensure product safety and integrity, demonstrating Cosway Co.'s commitment to compliance and quality improvement.