FDA EIR - World Organic Corp. - September 14, 2021

An FDA inspection of World Organic Corp., a dietary supplement repacker and labeler located in Huntington Beach, CA, was conducted from September 9-14, 2021. The inspection assessed compliance with regulatory guidelines for dietary supplements, following previous inspection findings in 2018. The inspection identified two significant violations documented on an FDA Form 483. First, the company failed to prepare written Master Manufacturing Records (MMRs) for each batch size of dietary supplements, confusing them with batch records, a repeat observation. Second, quality control personnel did not reject dietary supplements or labels when established specifications were not met. This was evidenced by the distribution of Vitamin A Fish Liver Oil that failed to meet weight and potency specifications, and both Vitamin A and Gingko Biloba products being distributed with inaccurate or incomplete labels regarding ingredients. Additional issues discussed with management included the lack of signed and dated review of Standard Operating Procedures by quality control, incomplete batch records missing equipment cleaning times and QC signatures, and a failure to document consumer complaints using the company's established forms. In response, management committed to immediately creating Master Manufacturing Records, verifying and updating all product specifications and labels, and implementing stricter adherence to internal procedures for batch record review and consumer complaint documentation.