NeoBiotech Global Corporation – FDA 483, May 13, 2019

NeoBiotech Global Corporation, an OTC drug manufacturer in Auburn, WA, was cited for numerous significant deficiencies during an FDA inspection. The firm lacked a functional quality control unit, written procedures for critical operations like complaint handling, raw material control, batch production, and process validation. Additionally, the inspection revealed inadequate control over equipment, labeling, and a complete absence of analytical testing for drug product release, indicating a severe lack of fundamental GMP compliance.