The US Food and Drug Administration (FDA) released the warning letter this week – issued April 19, 2018 – following an inspection at the API maker's Yunnan facility in China, 16-20 October 2017.
The letter cites data and quality deviations from current good manufacturing practice (cGMP) for active pharmaceutical ingredients (APIs) and notes the FDA’s decision to place the firm on Import Alert 66-40, as of February 8 this year.
According to the FDA, the firm’s laboratory equipment used to generate analytical data for batch release lacked restricted access: “All users could delete or modify files, and there was no mechanism to trace individuals who may have created, modified, or deleted data generated by computerised systems.”
This issue was flagged at an FDA inspection at the facility in 2015, however, at the latest visit, the FDA observed the company had not implemented any of the corrective actions required.
The Agency also noted Lijiang Yingua Biochemical and Pharmaceutical Co. lacked data relating to its API and intermediates testing.
“During our inspection, when we sought to reconcile assay results…you responded that you could not provide the electronic data from laboratory analyses on this equipment for the above period of several years.
“You explained that the electronic data in question had been deleted by accident and was no longer available,” said the FDA.
Among other deviations was the company’s approval of the certificate of analysis (COA) to release an API batch to its customer, before testing had been completed.
“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” said the FDA.
“We strongly recommend that you retain a qualified consultant to assist in your remediation,” it added.
The FDA has requested a detailed response to the letter, which included interviews of current and former employees “to identify the nature, scope, and root cause of data inaccuracies.”