# China NMPA Inspection - Chongqing Grelin Pharmaceutical Co., Ltd. - June 07, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/chongqing-grelin-pharmaceutical-co-ltd/978744be-64bd-4e2e-b4eb-b722b47a64db/
Source feed: China

> China NMPA unannounced inspection for Chongqing Grelin Pharmaceutical Co., Ltd. published June 07, 2016. An unannounced inspection of Chongqing Grelin Pharmaceutical Co., Ltd., conducted by the State Food and Drug Administration and Chongqing Municipal Fo

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Chongqing Grelin Pharmaceutical Co., Ltd.
- Company Name: Chongqing Grelin Pharmaceutical Co., Ltd.
- Publication Date: 2016-06-07
- Product Type: Drugs
- Summary: An unannounced inspection of Chongqing Grelin Pharmaceutical Co., Ltd., conducted by the State Food and Drug Administration and Chongqing Municipal Food and Drug Administration from April 14-17, 2016, revealed significant regulatory non-compliance. Prompted by a complaint, the inspection identified several critical issues. Key violations included the company leasing its production qualification for artificial bezoar raw materials and suspected illicitly purchasing and relabeling artificial bezoar, evidenced by discrepancies between sales, production, and material purchase volumes. Furthermore, the company failed to adequately define raw material sources and quality measures in its process specifications and did not adhere to established production procedures for artificial bezoar. Major material suppliers were not audited, and critical traceability systems were absent; there were no inbound or outbound ledgers, acceptance, or shipping records for raw materials and finished products, nor were storage location cards maintained. Batch production records also lacked crucial supplier and material details, hindering full traceability. These actions violated the "Drug Administration Law of the People's Republic of China" and relevant Good Manufacturing Practice (GMP) regulations. As a result, authorities mandated sealing all artificial bezoar raw material inventory, recalling all distributed products, and initiating an investigation into the illegal activities. The company's relevant GMP certificates have been revoked.

Company: https://www.globalkeysolutions.net/companies/chongqing-grelin-pharmaceutical-co-ltd/4587268c-26f4-481e-96ee-33e3eb1f4b88/