The FDA has issued Form 483 inspection reports to seven drug companies for a variety of GMP and other lapses, including problems with data integrity, complaint handling and visual examinations…
Healthcare regulators have set their sights on type 2 diabetes drug metformin to see if it contains unsafe amounts of N-nitrosodimethylamine (NDMA). Source: Drug GMP Report
Four U.S. drugmakers drew FDA warning letters for violations ranging from the use of contaminated water to the promotion of unapproved drug products. Source: Drug GMP Report
Ranitidine can generate N-nitrosodimethylamine (NDMA) when stored at higher temperatures, a research laboratory has found, raising new safety concerns. Source: Drug GMP Report
A drugmaker in the Czech Republic was listed on the EudraGMDP inspection database for serious deficiencies at its Prague facility including the presence of mold and dead insects. Source: Drug…
The FDA rapped drugmakers in China, India and Japan after discovering good manufacturing practice violations at their facilities. Source: Drug GMP Report
The FDA outlined its current thinking on the information sponsors of transdermal and topical delivery systems (TDS) should include in their NDAs and ANDAs in a draft guidance. Source: Drug…
The FDA issued warning letters to six companies for violations ranging from data integrity deficiencies to selling unapproved products. Source: Drug GMP Report
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) released draft advice for GMP inspectors on evaluating risk-based changes to pharmaceutical quality systems (PQSs). Source: Drug GMP Report
In a new draft guideline, the World Health Organization (WHO) offered recommendations on complying with data integrity, GMP documentation and recordkeeping requirements. Source: Drug GMP Report