# FDA 483 - Philips North America LLC - March 25, 2020

Source: https://www.globalkeysolutions.net/records/483/philips-north-america-llc/9f87ee6f-18b9-4d5c-a627-6a39cfa94005

> FDA 483 for Philips North America LLC on March 25, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Philips North America LLC
- Inspection Date: 2020-03-25
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Philips North America LLC in Bothell, WA, a medical device manufacturer, was cited for inadequate corrective and preventive action (CAPA) procedures. The firm failed to adequately establish procedures for CAPA, resulting in numerous Class 3 defibrillators being missed from Field Change Orders (FCOs) despite a Health Hazard Evaluation identifying a serious risk of injury or permanent impairment. The investigation into affected devices was significantly delayed, taking 355 days to identify all at-risk devices after determining a new FCO was required.

## Related Documents

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## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/paul-m-kawamoto/0a24b110-12de-4736-8d98-7a023ceec01e)
- [James R. Montero](https://www.globalkeysolutions.net/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.globalkeysolutions.net/companies/philips-north-america-llc/d7335702-bc34-4fb8-acdc-db91e81d2f8c

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822