# China NMPA Inspection - Jilin Bode Medical Immunotherapy Products Co., Ltd. - May 27, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/jilin-bode-medical-immunotherapy-products-co-ltd/73747e7d-71e8-4caf-b531-fb5ba3e7579e/
Source feed: China

> China NMPA unannounced inspection for Jilin Bode Medical Immunotherapy Products Co., Ltd. published May 27, 2016. An unannounced inspection conducted by regulatory authorities involving Jilin Bode Medical Immunotherapy Products Co., Ltd. revealed a critical compli

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Jilin Bode Medical Immunotherapy Products Co., Ltd.
- Company Name: Jilin Bode Medical Immunotherapy Products Co., Ltd.
- Publication Date: 2016-05-27
- Product Type: biologics
- Summary: An unannounced inspection conducted by regulatory authorities involving Jilin Bode Medical Immunotherapy Products Co., Ltd. revealed a critical compliance issue. The inspection, documented in a report published on May 27, 2016, uncovered that the company's production license had been officially revoked by the Jilin Provincial Food and Drug Administration on April 26, 2016. This significant finding indicates a failure by Jilin Bode Medical Immunotherapy Products Co., Ltd. to maintain the necessary operational authorizations required for manufacturing. While the report does not detail the specific reasons leading to the license revocation, its absence renders the company ineligible to produce its products under the established regulatory framework of the National Medical Products Administration (NMPA) and its provincial counterparts. Following this discovery, the State Food and Drug Administration (predecessor to NMPA) issued a directive. It instructed the Jilin Provincial Food and Drug Administration to promptly investigate and confirm the current status of all relevant product registration certificates held by Jilin Bode Medical Immunotherapy Products Co., Ltd. This action aims to ensure that no unauthorized or non-compliant products remain on the market and that all necessary regulatory measures are taken in light of the revoked production license. The enforcement highlights a commitment to public health and safety within China's pharmaceutical oversight system.

Company: https://www.globalkeysolutions.net/companies/jilin-bode-medical-immunotherapy-products-co-ltd/6f97b28b-59ef-4c0d-ba20-4c853e2783cb/