FDA Warning Letter: Q-Unit failed to document API release

In January 2026, the U.S. FDA issued a Warning Letter to the Indian company "Chemspec Chemicals Private Limited" after having inspected its site in July/August 2025.

The significant violation of CGMP regulations for Active Pharmaceutical Ingredients (APIs) and intermediates, which is mentioned in the Warning Letter, is listed as follows:

• "Failure of your quality unit to exercise its responsibility to ensure the API and intermediates manufactured at your facility are in compliance with CGMP."

This observation mentioned in the Warning Letter is related to the lack of Quality Oversight, Good Documentation Practices and Data Integrity principles. It is listed that the Q-Unit of the company missed to document the review and release of several APIs batches and that the company did not prepare and maintain batch records of the produced goods. No deviations or other investigations were triggered by the responsible Quality personnel. Several Data Integrity violations were also mentioned in the respective Warning Letter. It is also explained that most of the observations are repeated findings. That's why the US FDA mentioned a long list of Data Integrity remediations as well as CAPA measurements in the Warning Letter and strongly recommends to engage a qualified consultant who can assist the company.

Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA may refuse the admission of substances manufactured at this company.

To view the complete list of violations and the conclusion given by the U.S. FDA, please see the Warning Letter Chemspec Chemicals Private Limited.