News

Two reports were recently published showing that the FDA is once again carrying out more inspections. And this is also happening in the EU - despite the MRA.

A recent EU Statement of Non-Compliance with GMP attests an Indian pharmaceutical company that it does not meet GMP requirements. The problem was that critical medicinal products could have been potentially affected.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a contract testing laboratory in Uruguay. The inspection revealed significant CGMP violations, specifically related to the laboratory data integrity and documentation practices. Key issues included incomplete laboratory records, unreviewed out-of-specification (OOS) results, and lack of controls over electronic data and manual integrations.

The series of FDA inspections with multiple deviations continues with another Warning Letter to a Korean company. In this case too, inadequate analytical control of starting materials and raw materials, e.g. for ethylene and diethylene glycol, is part of the deviation list.