# China NMPA Drug Inspection - Shandong Ruian Pharmaceutical Co., Ltd. commissioned Chifeng Wanzhe Pharmaceutical Co., Ltd. - Tacrolimus ointment

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shandong-ruian-pharmaceutical-co-ltd-commissioned-chifeng-wanzhe-pharmaceutical-co-ltd/2cd6c01c-38c5-4c58-b7bc-d8d7d07f405b/
Source feed: China

> China NMPA drug inspection for Shandong Ruian Pharmaceutical Co., Ltd. commissioned Chifeng Wanzhe Pharmaceutical Co., Ltd. published August 18, 2023. Drug: Tacrolimus ointment. On August 18, 2023, China’s National Medical Products Administration (NMPA) released Announcement No. 36, detailing four

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 36 of 2023 from the National Medical Products Administration regarding 14 batches of drugs that did not meet the requirements.
- Company Name: Shandong Ruian Pharmaceutical Co., Ltd. commissioned Chifeng Wanzhe Pharmaceutical Co., Ltd.
- Publication Date: 2023-08-18
- Drug Name: Tacrolimus ointment
- Inspection Finding: The relevant substances did not comply with regulations.
- Action Taken: Risk control measures such as suspending sales and use, and recalling products were implemented; investigations were conducted into the reasons for non-compliance and rectification was carried out; and investigations were initiated into suspected illegal activities.
- Summary: On August 18, 2023, China’s National Medical Products Administration (NMPA) released Announcement No. 36, detailing fourteen batches of pharmaceutical products that failed to meet national quality standards. Testing performed by various regional institutes identified deficiencies across eleven manufacturers. Key companies named in the report include Chifeng Wanzhe Pharmaceutical (producing on behalf of Shandong Ruian Pharmaceutical), Zhejiang Jianfeng Pharmaceutical, and several traditional medicine producers such as Hebei Runhua Pharmaceutical and Anhui Xusong Traditional Chinese Medicine Pieces Co., Ltd. The inspection revealed several quality control violations: Tacrolimus ointment failed due to the presence of impurities, Olopatadine hydrochloride eye drops failed because of incorrect fill volumes, and multiple Traditional Chinese Medicine products—including stir-fried silkworm pupae and jujube seeds—showed non-compliance regarding appearance, ash content, and moisture levels. Governed by the Drug Administration Law of the People's Republic of China, the NMPA has ordered immediate actions to mitigate public risk. The manufacturers must suspend the sale and use of these products and initiate comprehensive drug recalls. Furthermore, the companies are required to investigate the root causes of these failures and implement effective rectification plans. Provincial regulatory bodies will continue to investigate potential illegal activities and are expected to disclose the results of these inquiries publicly to ensure industry transparency.

Company: https://www.globalkeysolutions.net/companies/shandong-ruian-pharmaceutical-co-ltd-commissioned-chifeng-wanzhe-pharmaceutical-co-ltd/68da7f76-8284-4729-99fe-5d141c74996a/