9/10 February 2023
In July 2022, the U.S. FDA issued a Warning Letter to the U.S. American company "Jost Chemical Co." after having inspected its site in January 2022.
The significant violations of cGMP regulations for active pharmaceutical ingredients (APIs), which are mentioned in the Warning Letter, are listed as follows:
Especially, the fourth observations mentioned in the Warning Letter is related to the lack of Laboratory Data Integrity. It is listed as an example that the firm failed to have "unique passwords for laboratory instruments used to generate analytical data for finished API products" and that the "analytical systems lacked controls to prevent users from deleting electronic data." The observed findings resulted in a long list of Data Integrity remediation activities and CAPA measurements requested.
Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA strongly recommends engaging a cGMP consultant to support the company in aligning their systems with cGMP requirements. Additionally, the U.S. FDA may refuse new applications or supplements listing the company as drug manufacturer until the site has addressed 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 Jost Chemical Co.