OR WAIT null SECS
July 03, 2019
FDA sent warning letters detailing violations of current good manufacturing practices to three companies that repack APIs.
July 02, 2019
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.
June 20, 2019
FDA sent a warning letter to Spectrum Laboratory Products, Inc. after an inspection found CGMP and misbranding violations.
June 19, 2019
The company is voluntarily recalling all unexpired products that are intended to be sterile because of a lack of sterility assurance.
June 13, 2019
Vida International received an FDA warning letter after an inspection found quality control violations.
June 11, 2019
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.
June 10, 2019
Kingston Pharma LLC received a warning letter after an FDA inspection found violations of current good manufacturing practices including inadequate quality control.
June 07, 2019
Two facilities owned by Pharmasol Corporation were cited for violations of current good manufacturing practices in a FDA warning letter.
June 05, 2019
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.
May 28, 2019
Expanded controlled substance capabilities enables Particle Sciences to develop and manufacture Schedule I–V drugs.