The FDA hit five drugmakers for testing lapses and other quality failures observed during inspections of their manufacturing facilities. Source: Drug GMP Report

Cosmaceutical Research Lab was hit with an FDA warning letter for serious violations uncovered during an inspection of the firm’s manufacturing facility in British Columbia, Canada. Source: Drug GMP Report

The FDA hit Tokyo-based drugmaker Takeda with a warning letter after an inspection revealed that manufacturing problems for its drug Natpara (parathyroid hormone) uncovered last year were still not resolved.…

The FDA has unveiled a new compliance program for inspections of combination products. Source: Drug GMP Report

A group of U.S. academics and pharmacists has proposed a quality rating system for prescription drugs that would allow bulk buyers to assess the quality of drugs before they make…

The FDA rapped Korean drugmaker Huons for lackluster testing procedures and laboratory controls observed during an inspection. Source: Drug GMP Report

Pharma is pushing back against a slew of proposals by lawmakers to do away with U.S. reliance on foreign drug manufacturing. Source: Drug GMP Report

European officials cited Indian API maker Dishman Carbogen Amcis for serous quality failures found during an inspection of its facility in Gujarat. Source: Drug GMP Report

An FDA investigator found lapses in good manufacturing practices in an inspection of Time-Cap Laboratories’ drug manufacturing and repackaging facility in Farmingdale, New York. Source: Drug GMP Report

The FDA cited active pharmaceutical ingredient (API) manufacturer Abbey Color for failing to properly qualify its suppliers and other quality lapses at its Philadelphia, PA facility. Source: Drug GMP Report