FDA EIR - Basic Research, LLC - August 02, 2017

The FDA inspected Basic Research, LLC, a dietary supplement packager and distributor in Salt Lake City, UT, from July 31 to August 2, 2017. This inspection, conducted under specific Compliance Programs (CP 7321.008 and 7321.005) for dietary supplements and food labeling, reviewed the company's Current Good Manufacturing Practices (cGMPs), sanitation, complaint handling, and recall procedures, focusing on products such as Zantrex Black and Relacore Extra. No formal FDA Form 483, Inspectional Observations, was issued, indicating that no significant deficiencies were identified that required a formal observation document.

However, two primary areas were discussed with management. First, the Master Manufacturing Records (MMRs) used for bottling, packaging, and labeling were not specific to individual batch sizes, for which the firm was asked to provide a written justification. Second, the FDA highlighted concerns regarding potential inappropriate disease claims and the substantiation of health claims on various products. Specifically, a product named "IBS Relief with Probiotics" implied a disease treatment claim, and several affiliated product websites (NuraDyne, Vysera-CLS, SeroVital-hgh) featured strong health claims that require robust scientific backing. Basic Research, LLC committed to formally respond to the FDA's letter regarding the IBS Relief claims and to engage with the Denver District Compliance Office to determine the necessary documentation for substantiating other product claims. Additionally, the company agreed to update its Standard Operating Procedure for returned dietary supplements to explicitly include quarantining products upon receipt.