Audits and Inspections

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

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

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

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

This article explores the evolution of FDA’s approach to inspections of drug and biologics manufacturing facilities during the COVID-19 pandemic.

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

Concerns over vulnerability in the supply chain has increased pressure on FDA to renew site visits of domestic and foreign facilities.

Auditing distribution suppliers provides understanding and documentation of the services performed, says Siegfried Schmitt, vice president, Technical at Parexel.

FDA sent a warning letter to Allay Pharmaceuticals for inadequate written procedures; inadequate out-of-specification testing; inadequate stability testing; and inadequate quality control oversight.

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

Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, Inc., provide simple answers to frequently asked questions regarding regulatory inspections, although many of the concepts can be applied to internal and supplier audits as well.

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

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

Customceutical Compounding was sent a warning letter by FDA after investigators found deficiencies in the production of sterile drug products.

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

The amount of detail included in SOPs may help a company stay compliant, says Susan J. Schniepp, Distinguished Fellow at Regulatory Compliance Associates, LLC.

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

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

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

The UK's MHRA will resume on-site risk based GxP inspections from September 2020.

A new FDA guidance provides answers to questions about when the agency will seek to visit a site during the COVID-19 pandemic and how it will respond when a needed inspection cannot be conducted safely.

FDA relies on risk assessments, border inspections, and compliance histories in place of routine audits during the COVID-19 pandemic.

FDA sent a warning letter to ACRX Specialty Pharmacy Inc. detailing violations of the Federal Food, Drug, and Cosmetic Act and deficiencies in sterile manufacturing practices.

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

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.

483s and Warning Letters Point to Inadequate Quality Oversight

Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.

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.