# China NMPA Inspection - Tonghua Xinghua Pharmaceutical Co., Ltd. - July 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/tonghua-xinghua-pharmaceutical-co-ltd/49de3ae9-6a36-4c5a-8ee6-921e0a4af459/
Source feed: China

> China NMPA unannounced inspection for Tonghua Xinghua Pharmaceutical Co., Ltd. published July 09, 2018. An unannounced inspection by the State Food and Drug Administration Verification Center identified critical non-compliance at Tonghua Xinghua Pharmace

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Tonghua Xinghua Pharmaceutical Co., Ltd.
- Company Name: Tonghua Xinghua Pharmaceutical Co., Ltd.
- Publication Date: 2018-07-09
- Product Type: Drugs
- Summary: An unannounced inspection by the State Food and Drug Administration Verification Center identified critical non-compliance at Tonghua Xinghua Pharmaceutical Co., Ltd. The inspection, focusing on Ferric Ammonium Citrate Vitamin B1 Syrup II and concluding before July 2018, revealed significant deviations from regulatory standards and the "Good Manufacturing Practice for Pharmaceuticals (2010 Revision)". Key violations included unauthorized changes to the approved prescription, where the company quadrupled the preservative ethylparaben and introduced 95% ethanol into its Ferric Ammonium Citrate Vitamin B1 Syrup II formula. This unauthorized alteration impacted 24 product batches manufactured between January 2017 and March 2018. Serious data reliability issues were also uncovered. These involved falsified batch production records and material issuance logs, along with selective use of electronic data where inconsistent analytical results were discarded without investigation. Furthermore, laboratory personnel were granted inappropriate access permissions, allowing data clearing, deletion, and system configuration modifications on critical analytical instruments. Lastly, the company's cleaning procedures and validation for the oral liquid production line were deemed ineffective. Deficiencies included inadequate consideration of sampling locations and residue testing sensitivity during validation, alongside operational failures resulting in residual liquid in supposedly cleaned equipment. These findings indicated a severe risk to product quality. Consequently, the Jilin Provincial Food and Drug Administration was instructed to revoke the company's relevant GMP certificates and initiate legal proceedings against Tonghua Xinghua Pharmaceutical Co., Ltd. for its unlawful activities.

Company: https://www.globalkeysolutions.net/companies/tonghua-xinghua-pharmaceutical-co-ltd/854f738e-ab96-443d-b164-0098e2c39a7e/