Hunan Dongting Pharmaceutical Co., Ltd. – FDA EIR, Mar 6, 2015

An FDA inspection was conducted at Hunan Dongting Pharmaceutical Co., Ltd., situated in Deshan, Changdeshi, China, between March 2 and March 6, 2015. This comprehensive, routine Good Manufacturing Practice (GMP) inspection specifically focused on the company's manufacturing operations for human drug substances. The regulatory framework for this inspection was guided by FDA's CP 7356.002F, pertaining to Active Pharmaceutical Ingredient Manufacturing Inspections, and utilized ICH Q7A as a primary reference standard. The inspection covered critical operational systems, including Quality, Production, Materials, Facilities and Equipment, Laboratory, and Packaging and Labeling. Significantly, the inspection did not lead to the issuance of an FDA Form 483, which lists objectionable conditions or practices. Although no formal violations were cited, three specific "items of concern" were identified during the process. These concerns were thoroughly discussed with the firm's management, who demonstrated full cooperation and promptly implemented corrective actions before the inspection's conclusion. As a result of the immediate resolution of these items, no further regulatory actions were required by the FDA. The inspection ultimately concluded with a "No Action Indicated (NAI)" classification, reflecting the satisfactory compliance status of Hunan Dongting Pharmaceutical Co., Ltd. at the time of the review.