The FDA, which banned products from a South Korean sterile manufacturer last spring, has now followed up with a warning letter that says it has repeated practices that put its sterile drugs at risk for contamination.
In May, the FDA placed Hanlim Pharm in Seocho-Dong, South Korea, on import alert, banning all of its drugs from coming into the U.S. The company specializes in sterile ophthalmic drugs. A warning letter, sent earlier this month and posted this week, berated the plant not only for sloppy aseptic practices but also for data integrity issues, including supervisors openly backdating records.
The FDA said its inspection from earlier this year found that an operator had touched equipment in one ISO area and then set up equipment in another area without disinfecting his hands. The letter pointed out that the practice could transfer microorganisms from the ISO-7 area to the surfaces and components in the ISO-5 aseptic filling zone, posing “a significant risk of microbial contamination.”
Operators also started and stopped lines to clear bottle jams, often leaning over bottles, again putting them at risk of contamination.
The company said it would make filling-line changes, but the FDA pointed out that similar promises had been made in 2014 when Hanlim Pharm was cited for a similar violation. The FDA said that the company needed to come up with detailed plans that included independent risk assessments and a corrective plan that ensures “routine and effective supervisory oversight during manufacture of each batch.”
As for records, the agency also wants a CAPA plan for data integrity and for providing security and audit trails on computerized record keeping. The FDA said a consultant was a good idea if the company expects to meet all FDA GMP requirements.
The FDA has cited a number of well-known South Korean drugmakers this year, including Celltrion, whose issues put a number of drug approvals at risk, among them Teva’s highly anticipated migraine drug. Celltrion quickly resolved the issues and Teva’s drug was approved last month.