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May 22, 2019
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.
May 15, 2019
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.
May 07, 2019
FDA sent a warning letter to Dong Yuan Technology Co., Ltd. detailing CGMP violations including failure to follow laboratory and process controls.
May 02, 2019
We need to understand both sides when it comes to audits, says Siegfried Schmitt, PhD, vice-president, technical, PAREXEL Consulting.
April 30, 2019
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.
April 18, 2019
The company passed a seven-day FDA surveillance GMP inspection and announced two upcoming manufacturing partnerships.
April 16, 2019
FDA sent a warning letter to RIJ Pharmaceutical LLC after an inspection of the company’s Middletown, NY facility found CGMP violations.