Luohe Nanjiecun Pharmaceutical Group Pharmacy Co., Ltd. (afterwards named as Luohe Nanjiecun) located in Luohe City, Henan Province, China, is a pharmaceutical company with 33 years experience of manufacturing API. Luohe Nanjiecun was inspected by US FDA on September 23-27, 2019, inspector of US FDA had signed FDA483 form on September 27, 2019, Luohe Nanjiecun must provide FDA483 correction responses and deliver relevant correction data to US FDA in regulated period.

Luohe Nanjiecun had received DMF deficiencies letter from US FDA on May 13, 2020, Luohe Nanjiecun should correct its DMF according to DMF deficiencies and deliver correction responses to US FDA.

Foshan RuiTong Consulting Co., Ltd. (afterwards named as RuiTong) is a GMP consulting and execution company located in Foshan City, Guangdong Province, China, its main service contents include GMP consulting and execution, DMF/CEP/ASMF/WHO PQ registration, Audit.

Since December 12, 2019, RuiTong had fully participated in implement of deficiencies correction project. Based on deficiencies contents, US cGMP requirements and DMF registration requirements, RuiTong had prepared detailed corrective actions and schedule for FDA 483 deficiencies and DMF deficiencies of Luohe Nanjiecun, and leaded Luohe Nanjiecun to implement relevant corrective actions，Luohe Nanjiecun had finished corrective actions for FDA483 deficiencies in regulated period, and all relevant correction data had been delivered to US FDA on April 18, 2020. Corrective actions for DMF deficiencies had been finished, DMF deficiencies responses were delivered to USFDA on October 30, 2020.

Luohe Nanjiecun had received EIR from US FDA on September 12, 2022, Luohe Nanjiecun had passed the US FDA inspection and review of DMF, Luohe Nanjiecun has been one of Chinese Pharmaceutical companies passed US FDA certification.

RuiTong throughout insists vision with “Customer Focus, Result oriented” and help customer do every detail well really. If you need to know more about our GMP and registration (CEP/DMF/ASMF/WHO PQ) services, please do not hesitate to contact us.

Foshan RuiTong Consulting Co.,Ltd.

Room 803, Fuwei Building, Huangqi, GuangFo Road No.1, Nanhai District, Foshan City, Guangdong Province, China

Website: http://www.gdruitong.cn/

Tel.: +86-13660057841, +86-13695153512

E-mail: ruitong01@gdruitong.cn