The US Food and Drug Administration (FDA) visited the facility in Danjiangkou, Hubei Province, in July and August this year and sent the warning letter to the firm earlier this month.
Among the significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API) cited in the letter, the Agency said Hubei Danao failed to demonstrate its manufacturing process could reproducibly manufacture an API meeting its predetermined quality attributes.
“You did not validate the processes used to manufacture numerous batches of (b)(4) API prior to commercial distribution. You did not perform process qualification studies and lacked an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality,” the letter stated.
The Agency also said the firm failed to follow its change management programme with its quality unit.
“Our investigator found numerous changes that were not adequately documented, and implemented without quality unit evaluation and approval per your procedure, Change Control. These changes included, but were not limited to, product specifications, test methods, analytical equipment, and cleaning procedures for the manufacturing of (b)(4) API.”
A lack of adequate test procedures was also referenced by the FDA which said an “analyst manually integrated a high performance liquid chromatography test for (b)(4) API despite the fact that the chromatogram lacked peak resolution,” as an example.
All drug and drug products made at the facility have also been place on FDA Import Alert 66-40 – ‘Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs’ – as of November 1.
According to Hubei Danao’s website, steroid products are the company’s core business, and the 98,000 square meter site makes yellow ginger, stigmasterol and steroid plants as basic raw materials along with diene, 16-17A-Epoxyprogesterone, 17A-hydroxyprogesterone as main materials for pharma.
The firm did not respond to a request for further information at the time of going to press.