FDA EIR - Symrise, Inc - May 23, 2019

An FDA inspection of Symrise, Inc., a synthetic menthol producer and distributor in Goose Creek, SC, was conducted from May 21-23, 2019. The inspection, carried out under Current Good Manufacturing Practices (CGMP) and Limited Scope Preventive Controls for Human Food (PCHF) guidelines (21 CFR Part 117), aimed to assess the firm's operations. Significantly, this inspection did not result in the issuance of a Form FDA 483, indicating no official observations of regulatory violations during this specific visit.

The inspector did, however, note some informal observations for consideration, such as the absence of spill containment barriers at crude menthol receiving and storage areas, and localized damage to flooring with water collection, though these were deemed not to impact product safety. It was highlighted that a previous 2015 inspection had identified issues with detector calibration and inadequate investigation of deviations. Commendably, the current report noted Symrise's voluntary correction in implementing reference standard analyses for detector calibration.

While no formal actions were mandated, management committed to investigating the feasibility of providing protective gloves for employees handling menthol, prompted by discussions on continuous skin contact safety. Additionally, the company's Senior Quality Manager agreed to consider resurfacing damaged floor areas to enhance facility aesthetics and reduce potential slip hazards. The firm demonstrated functional complaint management and recall procedures, with no reports of illness or product recalls found in relevant databases.