Lyne Laboratories, Inc. – FDA EIR, Sep 7, 2021

An FDA inspection of Lyne Laboratories, Inc., located in Brockton, MA, was conducted from September 7-8, 2021. The inspection primarily focused on the company's manufacturing operations for dietary supplements, specifically the product "Prostex," adhering to the "Dietary Supplements – Foreign and Domestic Inspections, Sampling, and Imports" regulatory framework. The inspection involved a comprehensive review of the facility, including observations of manufacturing areas, equipment cleaning and sanitization processes, and an extensive examination of records. These records covered receiving procedures, quality control operations, supplier qualification, component and finished product testing, product complaints, recall procedures, retention samples, and stability testing. Significantly, at the conclusion of this recent inspection, no Form FDA 483 (Inspectional Observations) was issued, indicating that no new violations or issues were identified regarding their dietary supplement manufacturing practices. This differs from a previous 2018 FDA inspection, which cited three observations related to the quality control unit, adherence to production and process control procedures, and establishing equipment cleaning and maintenance protocols for drug products. However, the current inspection did not include a follow-up on these prior drug-related findings. Thus, while past issues for drug manufacturing exist, the dietary supplement segment inspected showed no current deficiencies requiring immediate corrective actions from this particular review.