Federal regulators have cited ICN Pharmaceuticals Inc. for failing to address manufacturing problems involving its drug Trisoralen, which the company had stopped producing earlier this year.
The Food and Drug Administration said in a letter last month that the company hadn’t adequately responded to agency concerns about manufacturing problems at the Ohio plant where the drug was being made.
The Costa Mesa drug maker had halted production early in the year and alerted federal regulators. The FDA later issued a warning letter saying the company failed to address concerns about the manufacturing process. Then on May 6, the FDA wrote another letter saying the company’s response to the agency’s warning was inadequate.
A company spokeswoman said executives have responded in writing to the warning letter and that a meeting with agency officials is planned for this summer.
In its warning letter, the agency faulted the firm for not satisfying a range of problems the agency found during an inspection after production ceased. Following the inspection, from Feb. 19 to March 20, the agency cited the firm with failing to make sure the drug meets standard tests for dissolvability.
It also faulted the firm’s controls involving factors such as the size of drug particles, humidity, processing and storage.
Trisoralen, which treats a disorder involving skin discoloration, accounts for a small amount of the firm’s sales, a spokeswoman said.