FDA warning letter issued to an OTC Manufacturer

The US FDA issued a Warning Letter to International Laboratories Corp in Thailand for significant data integrity and documentation violations identified during an inspection. Key issues included:

1. Missing or Manipulated Laboratory Data: The manufacturer failed to provide complete and reliable data for chromatographic analyses. Several laboratory tests were fabricated, and original data for raw material and finished product analyses was missing.
2. Inadequate Controls Over Electronic Systems: The manufacturer lacked proper restrictions and controls on electronic systems used for testing, allowing employees to delete or modify raw data. Several instances of deleted electronic data were documented, and laboratory employees had administrator rights to alter files, folders, and timestamps.

In response, the manufacturer acknowledged deficiencies but did not provide a comprehensive assessment. The FDA required the company to:

• Conduct a full review of the data integrity issues.
• Assess the impact of these violations on product quality and patient safety.
• Implement corrective actions and consider appointing a Chief Integrity Officer.

For further details, the FDA Warning Letter is available on the FDA website.

25-04-2025