# China NMPA Inspection - Guangdong Yifang Pharmaceutical Co., Ltd - November 15, 2014

Source: https://www.globalkeysolutions.net/records/china_inspection/guangdong-yifang-pharmaceutical-co-ltd/60652ca8-ffe6-4864-9f9d-72be2ad5d713/
Source feed: China

> China NMPA unannounced inspection for Guangdong Yifang Pharmaceutical Co., Ltd published November 15, 2014. An unannounced inspection by the State Food and Drug Administration on October 28-29, 2014, uncovered critical manufacturing deficiencies impacting Gu

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Guangdong Yikang Pharmaceutical Co., Ltd.
- Company Name: Guangdong Yifang Pharmaceutical Co., Ltd
- Publication Date: 2014-11-15
- Product Type: Drugs
- Summary: An unannounced inspection by the State Food and Drug Administration on October 28-29, 2014, uncovered critical manufacturing deficiencies impacting Guangdong Yikang Pharmaceutical Co., Ltd. and Shaoguan Residents Pharmaceutical Co., Ltd. The inspection was triggered by a national sampling that detected trace amounts of antipyretic analgesic anti-inflammatory drugs in anti-osteoproliferative tablets (batch number 120201) linked to Guangdong Yikang. Further investigation revealed that Shaoguan Residents Pharmaceutical Co., Ltd. was the actual manufacturer of the contaminated product. Investigators confirmed cross-contamination between anti-osteoproliferative tablets and chlorpheniramine maleate tablets during production at Shaoguan Residents. This serious issue stemmed from inadequate oversight of multiple contract manufacturers, the alternating use of production lines for both traditional Chinese and Western medicines, and insufficient cleaning protocols. These practices constituted clear violations of the Drug Administration Law and Good Manufacturing Practice (GMP) regulations. Consequently, the Guangdong Provincial Food and Drug Administration revoked the GMP certificates for both Guangdong Yikang Pharmaceutical Co., Ltd. and Shaoguan Residents Pharmaceutical Co., Ltd. A comprehensive recall of the affected products has been initiated, and the case remains under active investigation for further regulatory action.

Company: https://www.globalkeysolutions.net/companies/guangdong-yifang-pharmaceutical-co-ltd/07846ca9-3cec-469c-8361-754173210343/