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The FDA slammed a Chinese active pharmaceutical ingredient (API) manufacturer for using a supplier of potentially contaminated heparin and for restricting access during an inspection. Read More
The FDA was not happy that Elite Laboratories’ quality unit failed to validate and review various product batches before distribution, landing the generic drug maker a Form 483. Read More
Manufacturers operating in Europe should report any product-quality defect to the drug application holders and individual EU regulatory bodies if the incident requires a recall or creates supply restrictions, according to a revised chapter of a European Commission guideline on GMPs. Read More
Compounding pharmacies are asking the FDA to overhaul its guidance for interim good manufacturing practices, contending the recommendations for such things as the cleanliness of air filters and presence of particulates are unclear and subjective. Read More
Within two years, the FDA will begin assigning all facility inspections to specialized teams that have detailed expertise in the lifecycle of the particular drug that is subject to inspection. Read More
A Chinese active pharmaceutical ingredient (API) maker was slammed by the FDA for falsifying batch record signoffs and product labeling, the latest international drugmaker to be caught in the agency’s crackdown on poor data integrity. Read More
FDA investigators and their European counterparts are comparing training and auditing procedures as the first steps in a new push to increase mutual reliance on each other’s inspections. Read More
Manufacturers operating in Europe should report any product-quality defect to the drug application holders and individual EU regulatory bodies if the incident requires a recall or creates supply restrictions, according to a revised chapter of a European Commission guideline on good manufacturing practices. Read More