FDA Warns Indian Drugmaker for Dropping Ball on Testing
The FDA hit JHS Svendgaard Hygiene Products with a warning letter for serious GMP failures at its drug manufacturing facility in Himachal Pradesh, India.
An agency inspection revealed the company failed to adequately test incoming active pharmaceutical ingredients for purity, strength and quality, relying instead on certificates of analyses from the supplier.
The quality unit failed to investigate and report deviations that put drug products at risk, the agency said. It also noted a lack of identity testing for finished drug products.