Philips Healthcare received a warning letter from the Food and Drug Administration over conditions at a Cleveland plant that makes CT, PET-CT and SPECT scanners, according to a notice the FDA made public on its website.

In the June 7 letter, the agency said it found nearly a dozen violations at the Cleveland factory from inspections it carried out between August 25 and Dec. 3 last year. Violations include what the FDA said was lack of following correct procedures for a software fix, questions about testing design inputs for a PET-CT unit and delays in answering or reporting customer complaints.

In the letter, the FDA said Philips' quality control responded to the agency's observations in December, February and March. But for most responses, the agency said "the adequacy of the responses cannot be determined at this time."
The FDA asked for Philips to reply within 15 working days, detailing steps it would take to correct the violations and prevent them from happening in the future. The agency also requested the company get an independent audit of the plant's manufacturing and quality assurance practices, and have the company's CEO sign off on a report stating that corrections called for by the agency were started or completed.

"You should take prompt action to correct the violation(s) addressed in this letter," the agency said.

A Philips spokesman told the Wall Street Journal that the company was already working on quality changes and had brought on an independent consultant to inspect the plant. The company plans on submitting its report to the agency by the end of the month.

Although warning letters can cause the FDA to delay new products built at the plants, Philips said it did not expect the letter to interfere with new product approvals. Machines are still being built for sale at the plant, the company said.

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