FDA EIR - Lyne Laboratories, Inc. - January 25, 2018

An FDA inspection of Lyne Laboratories, Inc., located in Brockton, MA, was conducted from January 10 to January 25, 2018. This comprehensive review focused on the company's adherence to current Good Manufacturing Practices (cGMP) for drug products. The inspection identified three main observations on Form FDA 483. First, the Quality Control Unit did not fully follow its established procedures for compressed air system testing, specifically regarding the timely review and documentation of air sample test results. Second, the company failed to follow its written production and process control procedures during manufacturing operations. This included personnel being unable to confirm a critical mixing speed and improperly breaking a vacuum in a compounding kettle using an unfiltered air connection, contrary to established protocols. Third, there was an absence of written procedures for the preventative maintenance of critical air filters used in compounding rooms. These findings highlight deficiencies in quality control oversight, adherence to manufacturing instructions, and equipment maintenance practices. Company management acknowledged the observations and committed to providing a written response within 15 business days, outlining their corrective actions. Additionally, a discussion item regarding the lack of an access log for a limited access refrigerated storage area was voluntarily corrected during the inspection.