FDA 483 - Den-Mat Holdings, LLC - December 07, 2023

An FDA inspection of Den-Mat Holdings, LLC in Lompoc, CA, identified significant deficiencies in the firm's quality control unit and material testing procedures. The firm failed to establish and follow written procedures for approving or rejecting critical specifications and did not adequately test incoming components or validate supplier analyses. These issues indicate a lack of robust quality oversight in drug manufacturing processes.