OR WAIT null SECS
March 16, 2017
FDA sent a warning letter to Lumis Global Pharmaceuticals Co. Ltd. detailing CGMP deficiencies regarding API repackaging, labeling, and misbranding.
March 15, 2017
The agency sent a warning letter to Badrivishal Chemicals & Pharmaceuticals detailing several CGMP violations.
March 09, 2017
The agency cited Morton Grove Pharmaceuticals for inadequate quality control procedures.
March 07, 2017
The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.
March 01, 2017
This article reviews experiences with the outcome of in-house audits, audits by third parties, and purchased audit reports.
February 28, 2017
The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.
February 21, 2017
Momenta’s fill/finish contract manufacturer, Pfizer, was cited in the letter.
February 16, 2017
FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.
February 15, 2017
The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.
February 07, 2017
FDA's Warning Letter to an Indian API manufacturer alleges cGMP violations and improper cleaning and validation