Warning Letter issued for an Indian API facility

In December 2024, the U.S. FDA issued a Warning Letter on its website to the Indian company "Micro Orgo Chem" after having inspected its site in April 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 adequately validate written procedures for the cleaning and maintenance of equipment."
• "Failure to demonstrate your manufacturing process can reproducibly produce an API that meets its predetermined quality attributes. Also, there is no assurance that your facilities, equipment, and testing methods are suitable for their intended use."
• "Failure to design a documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates."
• "Failure to prepare, review, and approve documents related to the manufacturing of API in accordance with written procedures."
• "Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP."

Especially, the third observation mentioned in the Warning Letter is related to the lack of stability data. It is listed that the manufacturer failed to have an appropriate stability program in place as well as that there were no stability chambers nor stability and reserve samples available at the site during the inspection. The ongoing stability studies and the respective tests are missing for three years (2021, 2022, 2023). According to the ICH Q7 guideline, section 11.54 "at least one batch per year of API manufactured (…) should be added to the stability monitoring program and tested at least annually to confirm the stability."

Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA highly recommended to appoint a consultant to ensure that the company will be CGMP compliant from now on. Since October 2024 the U.S. FDA put the facility on import alert. New applications or supplements of the company may withhold, until the U.S. FDA confirms the compliance of the facility with CGMP. A reinspection could be possible.
To view the complete list of violations and the conclusion given by the U.S. FDA, please see the Warning Letter Micro Orgo Chem.