Hong Kong Drug Manufacturer Receives Warning Letter

FDA issued a warning letter on Dec. 15, 2015 to Chan Yat Hing Medicine Factory for cGMP violations observed by FDA at the Hong Kong facility in July 2015. The letter states that the company had not yet responded to FDA’s request for detailed actions that the company plans on implementing to correct the violations.   

During FDA’s July 2015 inspection, the investigator found that the company failed to perform a variety of CGMP steps including the following:

• Test finished batches of drug product to evaluate the identity and strength of the drug’s API.

• Ensure the identity of APIs and excipients from suppliers.

• Demonstrate the acceptability of chemical and physical properties of products.

• Establish written procedures for production and process controls and quality control.

• Calibrate and maintain written records for the scale used to weigh components prior to their addition into the manufacturing process.

According to FDA, the company’s quality unit released products for distribution despite the CGMP violations.

FDA recommended the company hire a consultant with CGMP experience and stated, “Until you complete all corrections, and FDA confirms corrections of the violations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer. Your failure to correct these violations may also result in FDA continuing to refuse admission of articles manufactured at Chan Yat Hing Medicine Factory located at Flat 3, 9/F Fuk Keung Industrial Building, 66-68 Tong Mei Rd., Mongkok, Kowloon, Hong Kong, into the United States under Section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). 

“It is your responsibility to ensure your products contain only suitable inactive ingredients that are safe in the amounts administered and do not interfere with the effectiveness of the preparation or with suitable tests or assays to determine if the product meets its professed standards of identity, strength, quality, and purity [21 C.F.R. 330.1(e)].”

Source: FDA