Audits and Inspections

The company is voluntarily recalling all unexpired products that are intended to be sterile because of a lack of sterility assurance.

Vida International received an FDA warning letter after an inspection found quality control violations.

The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.

Kingston Pharma LLC received a warning letter after an FDA inspection found violations of current good manufacturing practices including inadequate quality control.

Two facilities owned by Pharmasol Corporation were cited for violations of current good manufacturing practices in a FDA warning letter.

A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.

Expanded controlled substance capabilities enables Particle Sciences to develop and manufacture Schedule I–V drugs.

Violations found by FDA included a failure to test product for API identity and strength, failure to validate outsourced materials, and a lack of written cleaning procedures.

Inspectors found a lack of control over computer systems and a failure to follow equipment cleaning and maintenance procedures.

FDA is examining and updating its programs for overseeing global operations and international affairs.

The agency is warning these manufacturers that they are putting consumers at risk with substandard manufacturing practices.

FDA sent a warning letter to Dong Yuan Technology Co., Ltd. detailing CGMP violations including failure to follow laboratory and process controls.

We need to understand both sides when it comes to audits, says Siegfried Schmitt, PhD, vice-president, technical, PAREXEL Consulting.

Regis Technologies reported that no Form 483 observations were issued following a routine FDA inspection.

The company’s center of excellence for advanced analytical testing passed GMP inspection from the European Medicines Agency.

The company passed a seven-day FDA surveillance GMP inspection and announced two upcoming manufacturing partnerships.

FDA sent a warning letter to RIJ Pharmaceutical LLC after an inspection of the company’s Middletown, NY facility found CGMP violations.

The agency sent a warning letter to Luen Fook Medicine Sdn., Bhd. for CGMP violations found at the company’s Malaysia facility.

FDA sent a warning letter to Hospira Healthcare India Pvt. Ltd. for CGMP violations including data integrity issues.

FDA sent a warning letter to Jubilant Life Sciences after investigators found CGMP violations.

A federal court ordered Guardian Pharmacy Services to stop producing compounded drugs.

The agency sent a warning letter to ANDAPharm, LLC after inspectors found the company’s cleaning and stability testing procedures were inadequate.

Hetero Labs recalls losartan potassium tablets due to presence of N-Nitroso-N-methyl-4-aminobutyric acid.

The Swiss Agency for Therapeutic Products has begun entering GMP compliance information in the European Union’s EudraGMDP database.

The two countries have been included in the mutual recognition agreement between the EU and US for GMP inspections.

Big data technology company, Aigenpulse, has been granted with International Organization for Standardization (ISO) 9001:2015 and ISO 27001:2013 certification.

FDA sent a warning letter to Skylark CMC Pvt. Ltd. after employees refused to let agency inspectors enter the company’s Ahmedabad, Gujarat, India facility.

Understanding the differences in inspection processes is the key to successful global expansion, according to Siegfried Schmitt, PhD, vice-president Technical, PAREXEL Consulting.

While pharma is proving its capabilities to develop novel therapies, the industry still needs to work on manufacturing innovation.

As Brexit rapidly approaches, the lack of clarity around the regulatory balance between the regions could lead to a reduction in standards.