Audits and Inspections

Will FDA Inspections Ever Be the Same?

July 20, 2020

Industry should be seeking more information from FDA on how it will restart its current inspection program.

FDA Works to Resume On-site Domestic Inspections

July 13, 2020

The agency is hoping to restart performing on-site domestic inspections during the week of July 20, 2020 depending on factors such as the status of COVID-19 in the state of inspection and local rules and guidelines.

Solving Pharma’s Quality Unit Identity Crisis

July 01, 2020

BioPharm International

483s and Warning Letters Point to Inadequate Quality Oversight

Pandemic Spurs Efforts to Boost Pharma Manufacturing in US

July 01, 2020

BioPharm International

FDA can better monitor quality production of domestic versus foreign firms.

Performing Remote Audits During the Pandemic

July 01, 2020

BioPharm International

It is important to consider the feasibility, benefits, and limitations of each type of audit in advance.

Following Guidelines During a Crisis

June 02, 2020

BioPharm International

Products must be manufactured in accordance with appropriate regulatory requirements, even during a pandemic, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

FDA Continues to Warn Companies Marketing Products to Treat COVID-19

April 15, 2020

The agency sent warning letters to three more companies for selling unapproved products claiming to treat COVID-19.

Critical Knowledge for Preparing Audits

April 02, 2020

BioPharm International

Addressing data integrity, quality culture, aging facilities, investigations/corrective actions and preventive actions, and risk management is key when conducting audits, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Being Vigilant in Supplier Oversight

April 01, 2020

BioPharm International

Risk assessments, audits, and good communication between sponsor and supplier are key elements of supplier oversight.

FDA Scales Back Domestic Inspections

March 18, 2020

FDA postpones routine domestic facility inspections due to the COVID-19 pandemic.