Audits and Inspections

July 1st 2024

Communication and meetings with FDA after receiving a warning letter demonstrates a serious response, says Siegfried Schmitt, vice president, Technical at Parexel.

June 21st 2024

The guidance document provides information about the agency’s intentions for assigning a goal date for a facility’s inspection readiness under GDUFA.

January 1st 2024

Reviewing regulatory documents, such as 483 forms and Warning Letters, can aid in determining a facility’s inspection readiness, says Siegfried Schmitt, vice president, Technical at Parexel.

December 15th 2023

The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.