# China NMPA Inspection - Shanghai AnDing Biotechnology (Tangyin) Pharmaceutical Co., Ltd. - December 05, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/shanghai-anding-biotechnology-tangyin-pharmaceutical-co-ltd/84babcf2-49ed-41f2-aedc-e701506f6cf9/
Source feed: China

> China NMPA unannounced inspection for Shanghai AnDing Biotechnology (Tangyin) Pharmaceutical Co., Ltd. published December 05, 2018. An unannounced inspection of Shanghai Anding Biotechnology (Tangyin) Pharmaceutical Co., Ltd., conducted by the State Food and Drug Administration wit

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Shanghai Anding Biotechnology (Tangyin) Pharmaceutical Co., Ltd.
- Company Name: Shanghai AnDing Biotechnology (Tangyin) Pharmaceutical Co., Ltd.
- Publication Date: 2018-12-05
- Product Type: Drugs
- Summary: An unannounced inspection of Shanghai Anding Biotechnology (Tangyin) Pharmaceutical Co., Ltd., conducted by the State Food and Drug Administration with findings summarized on November 30, 2018, revealed severe deficiencies in its quality management system, particularly concerning aminophylline-caffeine-chlorpheniramine products. Major violations included the company's failure to adhere to regulatory requirements outlined in "Drug Supplementary Application Approval Documents," resulting in 11 product varieties being marketed without the necessary sales approval from the Anyang Municipal Food and Drug Administration.

The inspection also highlighted a critical lack of quality risk assessment. For instance, a batch of Aminophylline Caffeine and Chlorpheniramine Maleate Capsules (batch 161001) was produced and sold without adequate assessment of production process risks or investigation into an out-of-specification caffeine content (107.1% against a 107.0% limit). Additionally, cross-contamination risk assessments were not conducted when new production lines were introduced.

Significant issues in laboratory data management indicated serious data integrity concerns. This included the absence of electronic storage and backup for thin-layer chromatography data, insufficient tiered access control for precision instruments like HPLC, GC, IR, and AAS, and untraceable HPLC data files lacking essential information and usage records. Furthermore, irregularities in reference standard management were identified, such as using uncalibrated raw materials and expired standards for product release without proper verification, and inadequate documentation for their use and inventory.

These findings indicate that the company's production quality management does not comply with the *Good Manufacturing Practice for Pharmaceuticals (2010 Revision)*. Consequently, the Henan Provincial Drug Administration has been instructed to revoke the company's relevant GMP certificates and pursue legal action.

Company: https://www.globalkeysolutions.net/companies/shanghai-anding-biotechnology-tangyin-pharmaceutical-co-ltd/b5eaf64f-6f86-44c3-9877-b4bff7beb7b2/