# China NMPA Inspection - Shaanxi Xiyue Pharmaceutical Co., Ltd. - May 12, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/shaanxi-xiyue-pharmaceutical-co-ltd/5c91717a-7f83-4f8c-be74-e6813e263466/
Source feed: China

> China NMPA unannounced inspection for Shaanxi Xiyue Pharmaceutical Co., Ltd. published May 12, 2018. Shaanxi Xiyue Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration and Shaanxi Provincial Foo

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Shaanxi Xiyue Pharmaceutical Co., Ltd.
- Company Name: Shaanxi Xiyue Pharmaceutical Co., Ltd.
- Publication Date: 2018-05-12
- Product Type: Drugs
- Summary: Shaanxi Xiyue Pharmaceutical Co., Ltd. was subjected to an unannounced inspection by the State Food and Drug Administration and Shaanxi Provincial Food and Drug Administration from March 15 to March 17, 2018, prompted by a complaint regarding diclofenac sodium raw materials. The inspection uncovered significant deviations from regulatory and internal standards. Key violations included a failure to follow process regulations, where diclofenac sodium batch sizes and crude product amounts in production records substantially differed from stipulated process regulations. Material management was chaotic, with 59,000 kg of purchased crude diclofenac sodium unaccounted for, and inconsistencies found between batch production records, warehouse ledgers, and manual records for finished product quantities. Additionally, the quality management department did not adhere to change procedures for critical production alterations and presented conflicting inspection data for the same crude product batches. These actions were deemed non-compliant with the Good Manufacturing Practice for Pharmaceuticals (2010 Revision). Consequently, the National Medical Products Administration instructed the revocation of the company's GMP certificate for diclofenac sodium raw material and initiated an investigation into suspected illegal and irregular activities.

Company: https://www.globalkeysolutions.net/companies/shaanxi-xiyue-pharmaceutical-co-ltd/2c2dfb62-b98f-4189-b05b-42c224bf136b/