# China NMPA Inspection - Xi'an Disai Biopharmaceutical Co., Ltd. - June 29, 2015

Source: https://www.globalkeysolutions.net/records/china_inspection/xian-disai-biopharmaceutical-co-ltd/bf96e3c1-9f86-407a-b5a6-d6d419ae3f53/
Source feed: China

> China NMPA unannounced inspection for Xi'an Disai Biopharmaceutical Co., Ltd. published June 29, 2015. An unannounced inspection was conducted by the State Food and Drug Administration (SFDA) and Shaanxi Provincial Food and Drug Administration at Xi'an 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on the on-site inspection of Xi'an Disai Biopharmaceutical Co., Ltd.
- Company Name: Xi'an Disai Biopharmaceutical Co., Ltd.
- Publication Date: 2015-06-29
- Product Type: biologics
- Summary: An unannounced inspection was conducted by the State Food and Drug Administration (SFDA) and Shaanxi Provincial Food and Drug Administration at Xi'an Disai Biopharmaceutical Co., Ltd. from May 21 to 22, 2015. The inspection uncovered serious non-compliance with regulatory standards. The company was found to be manufacturing injectable thymosin in a freeze-dried powder injection production workshop that had not obtained certification under the 2010 version of Good Manufacturing Practices (GMP). Evidence of active production in this uncertified facility included a pungent odor, fully connected processing equipment such as freeze dryers and ultrafiltration systems, the presence of colorless liquid in tanks, and water stains on the preparation room floor. Additionally, personnel were observed using alternative access routes to the workshop after the primary entry was closed. Company representatives admitted to producing the drug in this non-compliant facility since 2014, citing insufficient production capacity. These activities represent a severe breach of the *Drug Administration Law* and applicable GMP regulations. Consequently, the SFDA directed the Shaanxi Provincial Food and Drug Administration to revoke Xi'an Disai Biopharmaceutical Co., Ltd.'s GMP certificate, order an immediate cessation of all production, initiate a recall of all related products, and legally investigate and prosecute the identified violations.

Company: https://www.globalkeysolutions.net/companies/xian-disai-biopharmaceutical-co-ltd/050be6a7-b90b-47fe-8ae4-1781ec669211/