FDA EIR - Country Life, LLC - March 01, 2019

Country Life LLC, a dietary supplement manufacturer, packager, and distributor in Hauppauge, NY, was inspected by the FDA from February 20 to March 1, 2019, under the Dietary Supplement Compliance Program. This comprehensive review identified several significant compliance issues, leading to the issuance of a Form FDA 483, Inspectional Observations.

Key violations included the improper storage of components, where a torn bag of cocoa powder was observed with residue from an open bag of whey protein stored directly above, creating a contamination risk. The inspection also found a lack of adequate documentation for equipment controls, specifically an automated packaging line that consistently overfilled certain uniquely shaped tablets without sufficient monitoring or defined specifications for maximum tablet count. Furthermore, the firm failed to establish and follow clear laboratory control processes for setting appropriate specifications, with undefined acceptance criteria for certain dietary ingredient analyses. Lastly, documentation deficiencies were noted in the handling of product complaints, as several serious adverse event complaints lacked proper sign-offs and dates to indicate closure.

In response to these findings, Country Life LLC's management acknowledged the observations and committed to submitting a written response to the FDA within 15 business days, detailing their plans for corrective actions. This indicates required attention to their manufacturing, quality control, and documentation practices to align with regulatory expectations.