South Korean drug manufacturer Firson was slapped with a warning letter and placed on an import alert by the FDA in the wake of a plant inspection last November.
In a letter to Firson late last month and posted on the regulatory agency’s website this week, the FDA said its inspectors observed a number of significant violations at the company’s Seobuk-gu-based facility during their visit. They said the facility failed to demonstrate the ability of its aseptic processes to prevent microbial contamination, and there was no robust process to sterilize drugs.
Additionally, the FDA specifically pointed out Firson’s quality unit and investigations into cited problems.
"Your investigations lacked critical elements that help determine root causes. For example, the three investigations lacked an evaluation of the manufacturing process and associated records. You also did not routinely test complaint lots for all relevant quality attributes (e.g., sterility). Despite missing critical elements, your investigation concluded that 'there are no problems' with the implicated lots. Without thorough investigations, your quality unit lacks sufficient information to make reliable decisions on root causes and take effective action," the agency said.
The FDA placed Firson on an import alert in May.