FDA: Philips Healthcare Responded to Warning Letter

The U.S. Food and Drug Administration (FDA) found during an inspection at Philips Healthcare Inc.’s Andover, Mass., plant that the company was not meeting federal manufacturing standards, and the firm has since met those requirements, according to the federal agency.

The FDA had concluded that Philips, which manufactures medical devices such as patient monitoring cardiac care products and ultrasound transducers, did not use Current Good Manufacturing Practice requirements of the quality system. The agency will conduct a follow-up inspection to assure all changes have been met.

For the complete, warning letter, visit www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm186988.htm.