Cancer injections made to a standard strict regulators can find no fault with — patients here and abroad get medicines less likely to be recalled or contaminated. The US FDA inspected Gland Pharma's sterile oncology formulations and API facilities at Visakhapatnam and closed with zero observations. For an injectables maker selling into more than 60 countries, a clean inspection is close to the whole ballgame: it is observations and warning letters that stall approvals and cost customers.