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One firm kept several essential documents in different electronic systems that were not defined as part of the trial master file and were not accessible by inspectors. Read More
Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products. Read More
The FDA issued a Form 483 to Noven Pharmaceuticals after observing numerous problems at the transdermal drug manufacturer’s Miami, Florida facility. Read More
The FDA warned Phase 4 Pharmaceutical for repackaging deficiencies and inadequate drug distribution procedures at its Aventura, Florida facility. Read More
In response to the inspection observations, the firm sent the agency a quality control procedure that referenced food regulations and had no applicability to drug product manufacturing. Read More
The FDA warned Phase 4 Pharmaceutical for repackaging deficiencies and inadequate drug distribution procedures at its Aventura, Florida facility. Read More
The FDA is on track to complete standardized inspection agreements with every nation in the European Union next summer, one of the agency’s top international officials said Friday. Read More
The FDA has cut the amount of time it takes to issue post-inspection classification letters nearly in half over the past three years, one of the agency’s top inspection officials said Friday. Read More
The FDA hit drug compounder Fusion IV with a warning letter after an agency inspection found numerous problems at its outsourcing facility including the failure to meet conditions for section 503B exemptions from the agency’s drug approval requirements. Read More
The EMA noted a steep decrease in GMP inspections in its annual report for 2017, as well as a hike in inspections for good clinical practices and nearly double the amount of pharmacovigilance inspections than the previous year. Read More