Tag Archives: Biocon

More trouble for Biocon insulin plant in Malaysia as FDA flags six Form 483 observations

The road to certification for Biocon’s insulin facility in Malaysia was long, winding and full of potholes. Now comes a detour. The FDA has slapped the factory with Form 483, citing six observations that need to be addressed, the company said. The site makes the high-profile interchangeable insulin Semglee, but Biocon doesn’t expect the latest inspection… Read More »