FDA EIR - UAS Laboratories, LLC - November 18, 2021

UAS Laboratories LLC, a contract manufacturer of probiotic dietary supplements, underwent an FDA inspection from November 17-18, 2021. This routine surveillance inspection was conducted under compliance program 7321.008, adhering to the regulatory framework for Dietary Supplements (21 CFR 111). Unlike the previous inspection in 2019, which resulted in a Voluntary Action Indicated (VAI) classification and an FDA-483, the current inspection concluded without a formal FDA-483 being issued.

However, the FDA verbally discussed four main issues with management. These included the necessity of assigning due dates for crucial employee trainings, observed inadequate storage space leading to overcrowded conditions and materials in aisles, and a need for improved documentation practices, specifically regarding the proper placement of initials and dates for cross-outs on batch records. Additionally, the firm's out-of-specification (OOS) logs were found to be missing disposition decisions for each entry. The company committed to correcting these observations.

Significantly, the inspection confirmed that UAS Laboratories had successfully addressed the two prior FDA-483 observations from the 2019 inspection, which related to environmental monitoring quality procedures and laboratory documentation. The firm has since updated its environmental monitoring program and implemented detailed laboratory documentation forms to resolve these previous violations.