Audits and Inspections

Auditing for Good Distribution Practices

March 01, 2021

Auditing distribution suppliers provides understanding and documentation of the services performed.

Technology Introduces a New Normal for Quality Practices

February 10, 2021

Pharma companies find ways to maintain quality standards, despite pandemic-related restrictions.

Conducting Effective Audits During and Post Pandemic

February 01, 2021

With appropriate planning and the proper use of technology, remote auditing can be as effective and informative as in-person auditing.

FDA Inspection Shutdown Increasingly Delays Approvals

February 01, 2021

FDA puts applications on hold as the agency limits alternative oversight methods.

Now is the Time to Update the Quality Technical Agreement

January 01, 2021

Updating the quality technical agreement will clarify any expectations and limitations, says Siegfried Schmitt, vice president, Technical at Parexel.

Impact of Pandemic on Permanent Procedures

December 01, 2020

Virtual audits, virtual training, and more robust quality agreements may become positive impacts on the industry, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

FDA Finds CGMP Violations at Canadian Facility

October 20, 2020

FDA sent a warning letter to LEC Custom Products for a variety of CGMP violations including use of inappropriate equipment and processes.

Oklahoma Facility Given FDA Warning

September 18, 2020

The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.

FDA Sends Mylan Warning Letter

September 02, 2020

The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.

Georgia Facility Receives FDA Warning Letter

September 02, 2020

The agency sent a warning letter to Acella Pharmaceuticals detailing CGMP violations and failures to oversee contract manufacturers.