FDA 'strongly recommends' Syntec engage a GMP consultant

摘要

Syntec Pharma has received a stern warning letter from the FDA as to the multiple bad practices at its facility in the US. When inspectors looked at the facility near the end of 2020, they identified a whole host of issues that needed to be addressed to ensure safety of the final products. After some back and forth with the agency, Syntec volunteered some solutions in hopes of rectifying its concerns. However, as of the end of July 2021, these measures were found to be insufficient and a warning letter was issued. These bad practices included a few primary issues revolving around the organisation of the company's drug manufacturing facility and its lack of conformity with cGMPs. One aspect that the inspectors found to be a problem was that Syntec did not perform repackaging, relabelling, or holding of API under the appropriate cGMPs. This is normally done to avoid mix-ups and loss of API purity. This concern was exemplified when, after stating that it did not repackage any HPAPI, it was found that Syntec did in fact charge a customer for prepackaging a cytotoxic chemotherapy agent. On this basis, the FDA "strongly recommended" Syntec Pharma engage a GMP consultant.