# China NMPA Inspection - Wuhan Wujing Pharmaceutical Co., Ltd. - August 26, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/wuhan-wujing-pharmaceutical-co-ltd/3b41929b-38b0-4c44-b9f3-d79159d74167
Source feed: China

> China NMPA unannounced inspection for Wuhan Wujing Pharmaceutical Co., Ltd. published August 26, 2016. Wuhan Wujing Pharmaceutical Co., Ltd. was subjected to an unannounced follow-up inspection by the China Food and Drug Administration (CFDA) from April

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Wuhan Wujing Pharmaceutical Co., Ltd.
- Company Name: Wuhan Wujing Pharmaceutical Co., Ltd.
- Publication Date: 2016-08-26
- Product Type: Drugs
- Summary: Wuhan Wujing Pharmaceutical Co., Ltd. was subjected to an unannounced follow-up inspection by the China Food and Drug Administration (CFDA) from April 23-26, 2016. The inspection uncovered severe non-compliance with the Good Manufacturing Practice (GMP) standards for drug production.

Major violations encompassed critical issues with laboratory data reliability, including inadequate access controls on equipment, absence of audit trails, and evidence of fabricated or modified batch inspection records. Suspected falsification of experimental data was also identified. Extensive deficiencies in production management included suspected falsification of batch production records, overlapping production processes, and discrepancies in documentation and personnel signatures. Verification data also appeared to be falsified, with aseptic simulation tests conflicting with actual product filling times.

Additionally, significant quality control and assurance failures were noted. The company made unauthorized alterations to production processes, such as changes in batch sizes, sterilization methods, and product formulas, without proper change management or supplementary regulatory applications. Quality personnel were found to have neglected their responsibilities, evidenced by outdated product quality standards, absence of continuous stability studies, and failure to implement planned recalls for non-compliant batches.

Consequently, the CFDA instructed the Hubei Provincial Food and Drug Administration to revoke the company's GMP certificate for eye drops, supervise the recall of all marketed products, and initiate a comprehensive investigation. The findings were published on August 24, 2016.

Company: https://www.globalkeysolutions.net/companies/wuhan-wujing-pharmaceutical-co-ltd/7157fd48-11b3-45b8-bf86-44cd847797db