FDA Warning Letter caused by insufficient Documentation Practices

In February 2025, the U.S. FDA issued a Warning Letter to the Indian company "Tyche Industries Ltd" after having inspected its site in August 2024.

The significant violations of CGMP regulations for Active Pharmaceutical Ingredients (APIs), which are mentioned in the Warning Letter, are listed as follows:

• "Failure to record all quality-related activities at the time they are performed."
• "Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the APIs beyond the official or other established specifications."
• "Failure to test the identity of each batch of incoming production material."

Especially, the first observation mentioned in the Warning Letter is related to the lack of Documentation Practices and Data Integrity. It is listed as an example that the "documentation practices were not indicative of a facility that is in compliance with CGMP".

The observed findings resulted in a long list of Data Integrity remediation activities and CAPA measurements requested.

Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA placed the company on import alert. Additionally, the U.S. FDA may refuse new applications or supplements listing the company as manufacturer until the site has addressed all observations and fully complies with CGMP requirements, which might be checked by a further inspection.

To view the complete list of violations and the conclusion given by the U.S. FDA, please see the Warning Letter Tyche Industries Ltd.