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Sun Pharma hit with Form 483 after eight-year wait on design plan

US FDA delivers a Form 483 with four observations to Sun Pharma, with one noting that the company took eight years to create design plans for the production of one product.

AMPAC re-opens 50,000 gallon API facility in Virginia

After being acquired by SK Holdings, AMPAC re-opens its API manufacturing facility in Virginia as part of a growing investment in its US capabilities.

An ‘immutable record’: Blockchain pilot program to establish security frameworks

To investigate blockchain processes and make distribution information retrieval more efficient, the FDA tapped big name companies for a supply chain security pilot program.

FMD adopters faced 10% productivity decrease, says industry exec

Adoption of serialisation in order to comply to the FMD causes a productivity decrease and cost implications, says ACG Inspections’ CEO.

Pharmacy detects ‘high levels’ of new carcinogen in valsartan batches

Valisure detects fourth probable carcinogen in valsartan medication and criticises the US FDA’s daily exposure limits as lacking a ‘rational basis’ and being ‘of significant concern’.