Poor Documentation Practice caused U.S. FDA Warning Letter

In March 2021, the U.S. FDA issued a Warning Letter to a Chinese manufacturer of over-the-counter (OTC) drug products called "Foshan Biours Biosciences Co., Ltd." due to significant violations of cGMP regulations for finished pharmaceuticals.

Besides other failures listed in the FDA Warning Letter the firm failed to have an adequate release testing procedure of the respective product as well as the active ingredient in place. Furthermore, it is listed that the company failed to follow and establish written procedures for cleaning and maintenance of equipment as well as a written stability testing program for the respective active ingredient.

Good documentation practice and adequate and effective testing methods and procedures are key aspects of cGMP regulations and need to be considered to maintain cGMP compliant systems throughout the product life cycle. 

In relation to the observations mentioned above, the U.S. FDA now expects, for example, comprehensive assessments of procedures and methods as well as a list of the amended SOPs. Finally, the Warning Letter mentions that the FDA strongly recommends engaging a cGMP consultant to support the company in aligning their systems with cGMP requirements and to audit the respective quality systems to ensure cGMP compliance. The import alert, effective since October 2020, will remain in place until the Chinese manufacturer has concluded 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 to Foshan Biours Biosciences Co., Ltd.