FDA Issues Warning Letter to Chinese ManufacturerBy
Foshan Flying Medical Products, a Guangdong, China-headquartered supplier of healthcare products, has received a Warning Letter from the US Food and Drug Administration (FDA) for violation of current good manufacturing practice (CGMP) at its drug manufacturing facility its Guangdong, China. The FDA noted the violations during its inspection of the facility from February 20 to 23, 2017.
Among the violations cited by the FDA was that the company lacked an adequate quality control unit. It noted that the company failed to establish written procedures for numerous functions, including procedures for the quality control unit, complaints, deviations, investigations, and various other basic drug-manufacturing operations. The FDA also noted that the quality unit lacked documentation to demonstrate acceptability of batch manufacturing and quality.
The FDA also cited the company for releasing finished drug products without adequate acceptance testing. The FDA said in its letter that the company did not test to determine if products conformed to the identity or strength stated on the label. In addition, the FDA sad it did not adequately test for critical microbial attributes (e.g., absence of objectionable microorganisms, total count).
The company was also cited for failing to perform sterility testing. The agency said it lacks an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality.
In addition, the agency noted that one of the firm’s employees was only able to provide a single recent batch record for certain products, and staff stated that there were no other records when asked for them. The firm’s senior management stated that batch records are only retained for approximately six months after production. The batch record also lacked sufficient information necessary to determine whether the company products were manufactured properly. For instance, the batch records lacked batch numbers for raw materials used in the manufacturing process.
Additionally, the FDA said that the firm was unable to provide any cGMP-related training documentation and that the firm’s senior management further stated that no cGMP-related training has ever been provided to employees.
In response, the FDA said that the company must: establish an adequate quality control unit; describe its corrective action plan to ensure that it tests all drug product batches before releasing or rejecting them; describe its corrective action plan to ensure that all batches intended to be sterile are tested for sterility; detail its validation plan for ensuring an ongoing state of control; and provide details of its proposed training program to ensure that each person is equipped to effectively perform his or her assigned functions. The agency also noted that the company had been placed on import alert on May 23, 2017.
Source: US Food and Drug Administration