Audits and Inspections

Industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.

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

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.

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

With some FDA inspections on hold, will the US drug supply maintain its quality standards?

The agency is postponing the inspection of most foreign facilities through April 2020.

FDA sent a warning letter to Health Pharma USA after an inspection found the company’s quality unit was not properly overseeing its drug manufacturing operations.

The agency sent a warning letter to Henan Kangdi Medical Devices Co. Ltd after an inspection found CGMP violations that included a variety of failures of the company’s quality unit.

FDA sent a warning letter to Dercher Enterprises, Inc., DBA Gordon Laboratories, for CGMP violations and adulterated drug products.

The European Medicines Agency and its European partners have launched a pilot program for cooperation in the inspection of facilities that manufacture sterile drug products.

The successful inspection comes after the facility passed a pre-approval inspection in June 2019 from Japan’s Pharmaceutical and Medical Device Agency for an innovative drug.

Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as inadequate process control, root cause analysis, and corrective and preventive action (CAPA) in its warning letter.

Production and process controls, organization and personnel were the top problems found, while packaging and labelling citations increased in 2017 and 2018.

Sourcing hard-to-find ingredients and establishing a reliable supply chain can stretch the resources of a small- to mid-size pharma company.

The inspections took place at the company’s Charnwood, UK, Craigavon, Northern Ireland, and Audubon, PA, locations.

FDA sent a warning letter to Stemell, Inc. for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice and current good manufacturing practices.

A US District Court judge in Tennessee entered a consent decree of permanent injunction against Basic Reset and Biogenyx after multiple FDA inspections of the companies’ facility found violations of the Federal Food, Drug, and Cosmetic Act.

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

FDA sent a warning letter to NingBo Huize Commodity Co. after an investigation of the company’s Zhejiang facility found falsified quality documents.

FDA sent a warning letter to Emcure Pharmaceuticals, Ltd. because of sterility testing CGMP violations.

Spectrum Laboratory Products received an FDA warning letter after violations were found at its New Brunswick, NJ facility.

A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.

Machine vision systems have been an integral part of pharma manufacturing and packaging for many years and, with the introduction of stricter safety regulations, are set to become more vital.

Senior managers of OTC drug companies are on a learning curve, as FDA warning letters cite insufficient understanding of cGMPs and inadequate responses to prior 483s.

Performing a compliance gap assessment and focusing on six key factors in your facility’s process definition and controls can help your facility pass its next FDA inspection with flying colors.

FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.

Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.

FDA sent warning letters detailing violations of current good manufacturing practices to three companies that repack APIs.

Cultural and language discrepancies during an audit can be resolved using what many call a “playbook,” says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

FDA sent a warning letter to Spectrum Laboratory Products, Inc. after an inspection found CGMP and misbranding violations.