Chinese API manufacturer Henan Lihua drew a warning from the FDA over serious testing violations, inaccurate records and drug quality failures at its facility in Anyang, Henan.
The agency investigator who inspected the facility in December found numerous blank batch manufacturing records left in an open cabinet in the facility’s manufacturing workshop office. Among them were blank product release forms marked with a red quality assurance release stamp as “Permitted to Leave the Factory.”
The firm used the same instrument to perform both stability testing for multiple API and in-process analytical tests. After reviewing the audit trail, the investigator noted that the software was configured to allow continuous use of the “preview run” function and to routinely overwrite previous test runs, with only the final preview run results being saved.
The firm said it would replace the affected instruments, but the FDA said that solution was inadequate. The agency requested that the company put in place procedures to guarantee it will retain data required for quality unit review to ensure API compliance with all in-process and stability testing criteria.
The FDA placed the firm on an import alert on March 29 for automatic detention of its products at U.S. ports as a result of the violations.