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Headline : Philips receives warning letter from FDA regarding manufacturing facility

Read more from the original article on here at www.mobihealthnews.com.





Tags : #philips #receives #warning #letter #fda #regarding #manufacturing #facility


No. of Paragraph 24

Philips received a warning letter from the FDA in February, which the Agency posted on Tuesday, stating that an inspection of the tech giant's manufacturing facility in Suzhou, China, that makes CT and ultrasonography systems revealed it was not in compliance with the Quality System Regulation's good manufacturing requirements.

The FDA said an inspection of the facility in October showed the devices were "adulterated" in that the methods used in developing the products or in manufacturing, packaging, storage or installation do not conform to good manufacturing proactive requirements, according to the Code of Federal Regulations. 

Specifically, the Agency said the company failed to "ensure validation of the injection molding process used by [the] supplier of the custom-manufactured Philips Incisive CT Patient Interface Monitor (PIM) data cable." 

Philips Incisive CT PIM is considered a medical device, and manufacturers like Philips are required to submit medical-device reports when becoming aware of a device potentially causing or contributing to a death or serious injury.

Read more from the original article on here at www.mobihealthnews.com.


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