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July 25, 2017
FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.
July 18, 2017
Intertek seeks to bring cost efficiencies to the pharmaceutical supply chain through confidential shared audits.
The agency cited the Italian company for aseptic processing failures.
July 12, 2017
The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.
July 10, 2017
FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.
July 02, 2017
The opening presentation gives the company a chance to put their best foot forward, according to Siegfried Schmitt, principal at PAREXEL.
This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.
June 27, 2017
The agency sent a warning letter to Raritan Pharmaceuticals, Inc. after an inspection found quality testing and misbranding violations.
June 06, 2017
Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.
May 30, 2017
The company was cited for cGMP violations at its Irvine, California facility.