FDA EIR - Tongling Jieya Biologic Technology Stock Co., Ltd. - December 20, 2018

This FDA cGMP surveillance inspection was conducted on Tongling Jieya Biological Technology Stock Co. Ltd., a manufacturer specializing in over-the-counter (OTC) antibacterial wipes. The inspection, which occurred from December 17 to December 20, 2018, aimed to evaluate compliance with current Good Manufacturing Practices. It covered critical drug systems including Quality, Production, and Facilities & Equipment, in accordance with regulatory frameworks such as eNSpect Operation ID 110145 and CP7356.002 for Drug Process Inspections. Notably, the company had a previous FDA inspection in December 2016 where three observations were cited, primarily concerning the verification of testing methods, the completeness of laboratory records, and the documentation of sampling plan deviations. However, the most recent inspection yielded a significantly different outcome. At its conclusion, no FDA Form 483, detailing inspectional observations, was issued. The sole issue identified was a verbal observation regarding the temporary absence of hot water in handwashing facilities, which the company addressed and corrected immediately during the inspection. As a result, the inspection was classified as "No Action Indicated" (NAI), signifying that no further regulatory actions are required from the agency based on the findings of this inspection.