Steris Receives FDA Warning on Rhode Island Site

U.S. regulators have warned Steris Corp. about quality-control violations uncovered during an inspection of a Rhode Island plant, a recently released letter stated.

The company failed to maintain adequate procedures to deal with products that do not meet production requirements, the FDA said in a Sept. 25 letter.

The agency said inspectors visited the Coventry, RI, site of Steris unit Steris Isomedix in June and found practices were “not in conformity” with federal quality-control standards.

Steris spokesman Stephen Norton said the letter “was primarily related to documentation and record-keeping practices” at the facility.

“The sterility of the products processed at the facility are not in question. There have been no product recalls, and the facility is fully operational today,” Norton said.

The company has responded to the letter and “we expect that we will have ongoing communication with the FDA to satisfactorily resolve the issue,” he said.

The FDA findings do not apply to the 20 other Steris Isomedix facilities in the United States, Norton said.

SOURCE: Reuters