NEULAND LABORATORIES LIMITED – FDA 483, Aug 14, 2026

During an inspection of Neuland Laboratories Limited, an API manufacturer in Sangareddy, India, the FDA observed inadequate microbiological controls for the production of non-sterile active pharmaceutical ingredients. The firm failed to assess the risks associated with recovered Gram-negative microorganisms in their manufacturing system, which could pose risks to patient populations. Additionally, their standard operating procedure for handling isolates was found to be inadequate as it did not require risk assessment for all recovered organisms.