Kingchem is proud to announce a successful FDA audit for the manufacture of APIs under cGMP in Q4 2021.
Kingchem’s Wisconsin facility, acquired in 2018, was inspected by three FDA investigators over a five-day period. After the week long inspection, the investigators commended the facility for their quality systems and concluded the audit with a single item 483. The resolution for this minor observation was already initiated prior to the FDA close out meeting, at which the investigators again commended the QA team for their swift action. Kingchem looks forward to the formal written close out documentation from the FDA which is expected to be received in Q1 2022.
Kingchem Laboratories Inc. (St. Francis, Wisconsin, USA) has extended Kingchem’s capabilities to include full cGMP production for pharmaceutical intermediates as well as APIs. The North American manufacturing facility, Kingchem’s first in the US, offers an experienced team that can engage at every phase of drug development, from pre-clinical through commercialization. The production assets at Kingchem Laboratories range from pilot plant to full commercial scale and include a variety of materials of construction including glass-lined, stainless steel, and Hastelloy.
For further information concerning the facility, also see: https://www.kingchem.com/manufacturing/manufacturing-locations/kingchem-laboratories-inc/
For more information, contact Kingchem Life Science LLC.