RINATI SKIN LLC – FDA 483, Sep 22, 2022

RINATI SKIN LLC, a manufacturer in Hawthorne, CA, was cited for significant deficiencies in its quality control, laboratory testing, and production record-keeping during an FDA inspection. The firm failed to perform essential identity and strength testing on active ingredients and finished products, did not thoroughly investigate out-of-specification results, and lacked adequate written procedures and documentation for manufacturing processes and stability testing. These issues indicate a systemic breakdown in ensuring product quality and compliance.