FDA EIR - Symrise, Inc - June 06, 2012

An FDA surveillance inspection of Symrise, an Active Pharmaceutical Ingredient (API) manufacturer located in Goose Creek, SC, was conducted from June 4 to June 6, 2012. The inspection, carried out under Compliance Programs 7356.002F (API Process Inspection) and 7356.002B (Drug Repackagers and Relabelers), focused on the company's Quality, Production, and Laboratory Control systems, including menthol API production. No formal violations or FDA Form 483 (Inspectional Observations) were issued during this visit, resulting in a "No Action Indicated" classification.

This positive outcome followed a previous inspection in May 2011, which classified the firm as "Voluntary Action Indicated" due to several issues. These included failures in validating laboratory computer systems, inadequate controls to prevent unauthorized access to lab computers, insufficient investigations, an inadequate stability monitoring program, and delays in Good Manufacturing Practice (GMP) training. The 2012 inspection confirmed that Symrise had successfully implemented comprehensive corrective actions to address all these prior observations. While no new deficiencies were found, several recommendations were discussed with management to maintain and further enhance compliance.