FDA EIR - Cayman Chemical Company, Inc. - December 03, 2018

A full surveillance inspection of Cayman Chemical Company, Inc., an Active Pharmaceutical Ingredient (API) manufacturer, was conducted by the FDA from November 27 to December 3, 2018. This inspection, carried out under the FY19 workplan and CP 7356.002F, focused on the manufacturing of Latanoprost and AR-13324 (Netarsudil Mesylate) APIs, covering quality, facilities and equipment, materials, and laboratory systems. The primary violation identified, documented in a single FDA 483 observation, was the company's failure to perform growth promotion testing on growth media used for environmental monitoring during API packaging activities. Furthermore, the purchased growth media did not contain disinfectant neutralizers, which is crucial for accurate microbial recovery according to standards like USP <61> and ICH Q7. In response to the observation, company management committed to providing a written reply to the FDA within 15 business days. They also indicated plans to transition to growth media that includes disinfectant neutralizers and to assess the necessity for implementing growth promotion testing. The company was cooperative throughout the inspection, and no samples were collected. The inspection did not identify any new significant issues with previous observations from the 2014 inspection, which the firm had adequately addressed.