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Philips Healthcare’s Cleveland imaging center gets FDA warning letter

2:57 pm by | 2 Comments

Philips Healthcare‘s computed tomography and nuclear medicine headquarters in suburban Cleveland has received a warning letter from the U.S. Food and Drug Administration, primarily over quality control and record-keeping issues.

The FDA listed 15 specific violations uncovered during inspections of Philips’s imaging center in Highland Heights, Ohio last year. For example, the company failed to report to the FDA device malfunctions that “would be likely to cause or contribute to a death or serious injury if the malfunction were to recur,” according to the warning letter.

A Philips spokesman told the Wall Street Journal that the company will send the FDA a written response by the end of the month that will report on actions it has implemented, and will implement, to address the issues cited in the warning letter. The company has also hired an independent consultant to conduct a certified audit of the imaging facility.

Other problems cited in the warning letter include failing to investigate the cause of nonconforming products and failing to establish a procedure for receiving and evaluating complaints, plus various issues with employee training.

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Warning letters are considered by the FDA to be informal and advisory and don’t necessarily indicate that the FDA intends to take any punitive action against recipients.

The Philips spokesman said the issues cited in the letter weren’t holding up sales. “We continue to produce and ship scanners at this point,” he said

Netherlands-based Royal Philips Electronics employs more than 1,000 people at the Cleveland-area imaging center.

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Brandon Glenn

By Brandon Glenn MedCity News

Brandon Glenn is the Ohio bureau chief for MedCity News.
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2 comments
Mike Nunya
Mike Nunya

This is what Philips gets for over-working their employees. They believe in quantity of units sold, not quality. The real employees always let upper management know when there were issues, yet they went on deaf ears. Working people 7 days a week for months on end is not healthy for their workers, or the quality. People make mistakes when over-worked.

Adam Smitch
Adam Smitch

This is a true story Philips Gets FDA Warning Letter Involving Imaging System I would like to sharing the information to let the public know that Philips Medical Systems (R&D) department at Andover Massachusetts United States. All the new new medical device products are unsafe to use even after FDA approved. Making-up the documents to cheap the FDA. A new product XLR8 defibrillator is totally unsafe and highly to kill a person for lots of unknown issues as bellow 1. The device can be crashed at any period time (unstable) 2. All the features are based on the old MRx defibrillator from HP to enhancement, Engineering do not have experience skills 3. Ship produce to meet the dead line in the 2nd quarter Note: A big management issues (Research & Development) A few friend of mine are working in Philips Medical System at Andover Massachusetts United States. They told me the story that 1/3 of the employees there are tempory contactor and 1/3 are quarter century. most of them are do not do work Note: all the employees in Philips Medical System (R&D) in Andover Massachusetts are inheritance from Hewlett Parked therefore, it's a mess a retirement country club that Philip head quarter management do not realize. Due to Research and Development what they do just spend the funding for decade without produce and also hire a lot of contractor through third party agent with connection with a high pay contract without any medical experience job get through friend with the high pay salary. due to the company internal high level manager have connection to the third party contact company (Adecco. ACT, Qlogic...) They are sharing the profit... The Philips Medical System in Andover Massachusetts site is totally mismanagement