FDA EIR - Uni-Caps, LLC - January 07, 2020

An FDA routine, limited-scope inspection was conducted at Uni-Caps, LLC, a contract manufacturer of bulk soft gel dietary supplements located in Brea, CA, on January 7, 2020. The inspection focused on the firm's operations, particularly the production of Lecithin 1200 mg soft gel capsules, and was performed under the Import and Domestic Dietary Supplements Compliance Program 7321.008 and the Preventive Controls and Sanitary Human Food Operations Compliance Program 7303.040, as products are subject to the FD&C Act. The facility was undergoing maintenance and not in full production during the inspection, but quality control testing, raw material receipt, and finished product distribution were active. The previous inspection in 2017 was classified as No Action Indicated (NAI). Importantly, the current inspection concluded with no objectionable conditions or findings. Consequently, no FDA Form 483, Inspectional Observations, was issued, and no voluntary corrections were required. The firm maintains a food safety plan, is aware of the Food Safety Modernization Act (FSMA), and has established recall procedures, though no complaints or recalls were reported. The inspection found the facility to be in compliance with applicable regulatory frameworks.