FDA Warning Letter: Missing Stability Data of the API

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

In May 2021, the U.S. FDA issued a Warning Letter to an Indian over-the-counter drug manufacturer called "Biotek India" due to significant violations of cGMP regulations for medicinal products.

According to the FDA Warning Letter, the firm failed, among other things, to establish and follow a written stability program for their products. It is listed that, judging by the stability data provided by the inspected company, the manufacturer missed to include stability tests for the APIs and microbiological stability tests.

Stability testing and programs are key aspects of GMP regulations such as the ICH Q7 guideline and need to be considered in order to maintain GMP-compliant systems in manufacturing facilities.

Finally, the Warning Letter mentions that the U.S. FDA strongly recommends engaging a cGMP consultant to support the company to align their systems with cGMP requirements and to audit the site for ensuring the completion of the CAPA measures. The import alert, effective since March 2021, will remain in place until the Indian manufacturer has closed all observations and fully complies with cGMP requirements, which might be checked by another inspection.

To view the complete list of violations and the conclusion drawn by the U.S. FDA please see the Warning Letter Biotek India.