Dive Brief:
- The Food and Drug Administration issued a warning letter to China-based Henan Lihua Pharmaceutical, flagging violations of manufacturing standards following a regulatory inspection in December of last year.
- Henan Lihua was subsequently placed on import alert, meaning its products can be stopped at the U.S. border. Deviations cited included failure to review quality-related documents or maintain complete data, as well as running a system that does not ensure data integrity.
- As a result of the warning letter, the FDA can withhold approval of any new applications for drugs produced at the plant until deviations are corrected and compliance confirmed.
Dive Insight:
This latest warning letter for a Chinese pharmaceuticals manufacturer followed an FDA inspection that spotted significant deviations from current Good Manufacturing Practice for active pharmaceutical ingredients.
Henan Lihua is the latest of eight China-based drugmakers to be placed on the FDA's Import Alert 66-40 in 2018. Also known as the "Red List," this alert list flags imports for detention without physical examination.
The FDA investigator spotted blank batch manufacturing records, blank product release forms marked with a red quality assurance release stamp as "Permitted to Leave [the] Factory," and record issuance stamps for batch and page number left in an unlocked cabinet. According to the company, the product release form was "stamped in advance for convenience of release and warehousing of products" and the quality unit record controller "did not realize the risk of the damaged lock."
Despite the company reporting revisions and training, the FDA has requested additional assurance that staff have been retrained and standard operating procedures revised.
Henan Lihua's data management were also called into question. The company failed to retain raw data for in-process analytical testing, stating that the software did not allow retrieval or retention of the required data.
While the company has promised to replace the instruments and software and enable it correctly, the FDA wasn't satisfied.
To remedy the FDA's concerns, Henan Lihua must investigate the extent of the inaccuracies in data reporting and recording, carry out an assessment of the impact on drug safety and draft a management strategy that includes a global corrective action and preventive action plan.