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September 27, 2016
Employee empowerment is needed and it begins with senior leaders making adherence to cGMP regulations and compliance with SOPs the normal, easy, and rewarding thing to do.
September 23, 2016
Hebei Yuxing Bio-Engineering Co. Ltd. was cited for data integrity violations.
September 14, 2016
FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.
September 07, 2016
The Indian facility was cited for a range of quality and data integrity violations.
September 01, 2016
FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.
August 29, 2016
FDA issued a warning letter to College Pharmacy for multiple violations.
FDA issued a warning letter to the company for quality control violations.
The agency sent a warning letter to Cape Apothecary for adulterated drugs.
August 17, 2016
The Chinese facility was cited for data integrity violations.
Flawed testing and analysis and a failure to analyze the root cause of customer complaints were among the top problems noted in FDA's letter to the Florida-based transdermal drug manufacturer.