Audits and Inspections

FDA Inspections Back on Track?

August 02, 2021

Congress questions FDA on plans to catch up and move forward with facility inspections.

FDA Gives Green Light to Emergent BioSolutions to Resume COVID-19 Vaccine Manufacturing

July 30, 2021

Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.

FDA Under Pressure to Restore “Normal” Drug Inspections

July 28, 2021

FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.

The Value of FDA 483s and Warning Letters

July 02, 2021

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.

FDA Inspection “Roadmap” Acknowledges Continued Delays and Challenges Ahead

May 12, 2021

FDA expects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel imposed by the COVID-19 pandemic.

FDA on Inspections During and After Pandemic

May 10, 2021

The agency released a report that outlines inspectional activities conducted during the COVID-19 pandemic and discusses plans for future inspection operations.

Responding to FDA CAPA Requests

May 02, 2021

Understanding an FDA corrective and preventive actions request is step one in developing a robust plan to address CGMP deficiencies.

FDA Unveils Extensive Manufacturing Violations at Emergent

April 21, 2021

A FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.

FDA Shuts Down Emergent Vaccine Facility

April 20, 2021

FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.

FDA Weighs in on Remote Inspections

April 16, 2021

The agency will use technology for “voluntary remote interactive evaluations” for pre- and post-approval and other types of inspections.