# China NMPA Inspection - Guangdong Tongde Pharmaceutical Co., Ltd. - November 21, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/guangdong-tongde-pharmaceutical-co-ltd/648b6827-e3b0-4d0a-915c-51faa54a8e7f
Source feed: China

> China NMPA unannounced inspection for Guangdong Tongde Pharmaceutical Co., Ltd. published November 21, 2017. An unannounced inspection of Guangdong Tongde Pharmaceutical Co., Ltd. was conducted on June 5-6, 2017, by the State Food and Drug Administration and 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Guangdong Tongde Pharmaceutical Co., Ltd.
- Company Name: Guangdong Tongde Pharmaceutical Co., Ltd.
- Publication Date: 2017-11-21
- Product Type: Drugs
- Summary: An unannounced inspection of Guangdong Tongde Pharmaceutical Co., Ltd. was conducted on June 5-6, 2017, by the State Food and Drug Administration and the Zhanjiang Municipal Food and Drug Administration. The inspection focused on the company's traditional Chinese medicine extract production, specifically "Paeoniae Radix Alba Oil" and Patchouli Oil (Crude Oil).

Key violations identified included a lack of adequate facilities for cleaning and selecting raw materials for patchouli oil. Crucially, the process water used for crude patchouli oil extraction was directly sourced groundwater without any quality control or assessment. The company's warehouse for storing patchouli oil also lacked essential temperature control equipment, failing to meet requirements for cool storage.

A significant finding was the company's practice of purchasing crude oil and subsequently refining it in-house to produce the final product. This action directly violates Article 16, Paragraph 1, Item (5) of the "Implementation Rules for the Filing Management of Traditional Chinese Medicine Extracts," which prohibits altering or repackaging semi-finished or finished extracts.

Consequently, the State Food and Drug Administration has ordered the Guangdong Provincial Food and Drug Administration to revoke the company's "Drug GMP Certificate." Furthermore, all sold products must be recalled, and details of these violations are to be publicly recorded within the traditional Chinese medicine extract filing information.

Company: https://www.globalkeysolutions.net/companies/guangdong-tongde-pharmaceutical-co-ltd/f497c46f-b172-40c3-a3e8-cfac095ec7b3