# China NMPA Drug Inspection - Sinopharm Holding Tianhe Jilin Pharmaceutical Co., Ltd. - Tacrolimus ointment

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/sinopharm-holding-tianhe-jilin-pharmaceutical-co-ltd/fe7520c2-65db-452e-a5cd-2283e89f8183/
Source feed: China

> China NMPA drug inspection for Sinopharm Holding Tianhe Jilin Pharmaceutical Co., Ltd. published December 11, 2023. Drug: Tacrolimus ointment. In December 2023, the National Medical Products Administration (NMPA) of China issued Announcement No. 65, identifying f

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 65 of 2023 from the National Medical Products Administration regarding four batches of drugs that did not meet the requirements.
- Company Name: Sinopharm Holding Tianhe Jilin Pharmaceutical Co., Ltd.
- Publication Date: 2023-12-11
- 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; investigating the reasons for non-compliance and making concrete rectifications; initiating an investigation.
- Summary: In December 2023, the National Medical Products Administration (NMPA) of China issued Announcement No. 65, identifying four batches of pharmaceutical products that failed to meet quality standards. The inspections, conducted by various provincial testing institutes, revealed specific violations across several entities. Chongqing Jiang'anfang Pharmaceutical Co., Ltd. produced Anti-Cervicitis Tablets that failed microbial limit tests, while Sinopharm Holding Tianhe Jilin Pharmaceutical Co., Ltd. was flagged for a batch of Tacrolimus Ointment with excessive related substances. Additionally, Chunyuantang Clinic and Nagqu Huimin Hospital were cited for issues with Fried Silkworm Powder (total ash content) and Prepared Licorice Root (content determination), respectively. Operating under the framework of the Drug Administration Law of the People's Republic of China, the NMPA has mandated immediate risk control measures. These actions require the involved companies to suspend the sale and use of the non-compliant batches and initiate product recalls. Furthermore, the organizations must investigate the root causes of these failures and implement corrective actions. Provincial regulators have also been instructed to pursue formal investigations into potential illegal activities and publicly disclose their findings to ensure pharmaceutical safety and compliance.

Company: https://www.globalkeysolutions.net/companies/sinopharm-holding-tianhe-jilin-pharmaceutical-co-ltd/e62bf9ee-5f59-4038-badf-597f91997cbb/