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The FDA cited API manufacturer Syrmise of Holzminden, Germany, for eight violations including failure to investigate when a component, intermediate or API did not meet specifications. Read More
The FDA issued a flurry of Form 483s to drugmakers in the United States, Japan and India for issues ranging from inadequate record-keeping to cleanliness issues. Read More
Manufacturers and industry groups urged the FDA to develop guidance on its processes for assigning a lead center for the quality review of a combination product. Read More
Australia’s drug regulatory agency is urging drugmakers to reassess their quality control and data management systems after agency officials found frequent data integrity violations during GMP inspections over the past five years. Read More
Responses to internal audit reports are critical for GMP compliance because they fall under CAPA — so how a company responds to the findings of an internal audit is a key component of an effective audit. Read More