FDA EIR - United Pharma LLC - April 02, 2021

An FDA comprehensive inspection of United Pharma LLC, a dietary supplement contract manufacturer located in Fullerton, CA, was conducted from March 31 to April 2, 2021. The inspection aimed to assess compliance with regulations pertaining to dietary supplements and seafood processing, under guidelines such as Compliance Program Guidance Manual 7321.008. This included adherence to Good Manufacturing Practices (GMP) and Hazard Analysis and Critical Control Points (HACCP) principles where applicable.

The inspection involved a facility tour, observation of raw material storage, allergen identification practices, review of manufacturing processes for products like CoQ10, BM Co. Omega 3, and Vitamin E dl-Alpha Tocopheryl Ac 200 IU, and examination of equipment wash areas. Additionally, the firm's training program, sanitation procedures, hazard analysis for highly refined fish oil, complaint handling, and recall procedures were reviewed.

Notably, the inspection concluded with a "No Action Indicated" (NAI) classification. There were no reportable observations, deficiencies, or violations identified during this assessment. Consequently, no specific regulatory actions were required from United Pharma LLC as a result of this inspection, indicating the firm demonstrated compliance with the applicable regulatory frameworks at the time of the assessment.