FDA EIR - Bioiberica Nebraska Inc - October 24, 2018

An FDA surveillance inspection of Bioiberica Nebraska Inc. in Geneva, NE, was conducted from October 23-24, 2018. The inspection, guided by 21 CFR 117, focused on the company's operations as a dietary supplement ingredient warehouse and a manufacturer of the active pharmaceutical precursor Heparin, noting the firm had ceased manufacturing the dietary supplement ingredient Chondroitin Sulfate. The inspection revealed no violations, and consequently, no FDA Form 483 (Inspectional Observations) was issued; it was classified as "No Action Indicated" (NAI). Discussions with management covered receiving and storage, complaint and recall procedures, training, and pest control, alongside reviews of relevant Standard Operating Procedures and records. Firm management was informed about key regulatory frameworks including the Final Rules for Foreign Supplier Verification Programs, Preventive Controls for Human Food, FSMA Mitigation Strategies, and the Reportable Food Registry. They were specifically reminded of their ongoing responsibility to comply with the Food, Drug and Cosmetic Act and the Foreign Supplier Verification Program, particularly given their import of dietary supplement ingredients. While exempt from Subparts C and G of 21 CFR 117 for warehousing, they remain subject to current Good Manufacturing Practices (cGMPs).