Audits and Inspections

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

The Indian facility was cited for a range of quality and data integrity violations.

FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.

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.

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.

FDA issued a warning letter to contract testing laboratory, Adamson Analytical Laboratories, for CGMP violations.

Xiamen Origin Biotech Co., Ltd, was cited, not only for inadequate quality management, but for falsifying information on certificates of analysis, having fictional employees sign CoAs, and having employees lie to inspectors.

The company announced that its facilities and laboratories have completed FDA pre-qualification inspection.

GenPak Solutions is cited by FDA for cGMP violations at its Hilliard, Ohio facility.

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

FDA cited Guangzhou Haishi Biological Technology Co., Ltd. with CGMP violations.

The agency cited a Memphis drug compounder for misbranded drugs and a lack of appropriate sterile processes.

The issues cites the Taiwan facility with violations of current good manufacturing practice regulations.

FDA cited a Las Vegas compounding pharmacy for sterility violations.

FDA sent a warning letter to The Compounding Pharmacy of America for deficiencies in sterile manufacturing.

The agency cited KO DA Pharmaceutical Co. with cGMP violations.

FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.

The company received a warning letter at its Latina facility in Sermoneta, Italy following a May 2015 inspection.

The agency cited Tai Heng Industry with CGMP deviations, including failure to ensure data integrity.

FDA cited BBT Biotech GMBH for failing to comply with current good manufacturing practice in its German API manufacturing facility.

The agency cited Apotheca Supply, a repackager and relabeler of pharmaceuticals for CGMP violations.

A federal judge entered an order of permanent injunction against Paul W. Franck, the owner and operator of several compounding pharmacies in Florida.

The agency published guidance on data integrity as it is relates to CGMP compliance.

The agency cited Emcure Pharmaceuticals with CGMP violations.

The inspection confirmed that the facility was compliant with GMP guidelines.

Data integrity has become a more serious compliance problem at pharmaceutical manufacturing plants throughout the world.

FDA issued a warning letter to Chan Yat Hing Medicine Factory for CGMP violations.