FDA 483 - Rockline Industries, Inc - May 04, 2018

An FDA inspection of Rockline Industries, Inc. in Sheboygan, WI, a manufacturer of OTC, cosmetic, and medical device wet wipes, identified a significant deficiency related to written procedures. The firm lacked adequate procedures for the approval and rejection of components, specifically regarding the assessment of product impact from failures in water used for drug production. This included instances where water conductivity failures were noted without a corresponding product impact assessment.