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The FDA issued a warning letter to McCallum Manufacturing for deficiencies in process validation and quality control after an inspection of the firm’s Barnsley, South Yorkshire facility. Read More
The FDA warned Tris Pharma for manufacturing adulterated products at its Monmouth Junction, New Jersey facility, citing failures to properly investigate product defects and other deficiencies found during a March inspection. Read More
The FDA warned Phase 4 Pharmaceutical for repackaging deficiencies and the lack of procedures for drug distribution at its Aventura, Florida facility. Read More
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