FDA Warning Letter for Colombian API manufacturer

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

In April 2021, the U.S. FDA issued a Warning Letter to a Colombian API manufacturer called "Proquimes S A Productos Quimicos Especializados S.A." due to significant violations of cGMP regulations for Active Pharmaceutical Ingredients (APIs).

Amongst other deficiencies listed in the FDA Warning Letter, the firm failed to establish and perform a manufacturing process validation as well as a qualification of the equipment used for the manufacturing of the API in scope. Furthermore, it is noted that the company did not validate the cleaning process for the equipment used for the manufacturing of the respective API and that the lots of incoming raw materials, which were used for the manufacture of the API imported to the US, had not been sufficiently tested to ensure the identity of the material.

Validation of processes and qualification of equipment are key aspects of GMP regulations such as the ICH Q7 guideline and need to be considered in order to maintain cGMP compliant systems throughout the life cycle of APIs. 

Finally, the Warning Letter mentions that the U.S. FDA strongly recommends to re-check the guidance documents for cGMP regulations for APIs and to engage a cGMP consultant to support the company in aligning their systems with cGMP requirements. The import alert, effective since December 2020, will remain until the Colombian manufacturer has closed 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 Proquimes S A Productos Quimicos Especializados S.A.