# FDA 483 - Canadian Hospital Specialties Ltd. - February 02, 2017

Source: https://www.globalkeysolutions.net/records/483/canadian-hospital-specialties-ltd/1b8a0e1a-7f66-4f56-971a-a4ba947e02dc

> FDA 483 for Canadian Hospital Specialties Ltd. on February 02, 2017. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Canadian Hospital Specialties Ltd.
- Inspection Date: 2017-02-02
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Summary: An FDA inspection of Canadian Hospital Specialties, a medical device manufacturer, was conducted from January 30 to February 2, 2017. The inspection, addressed to President & CEO Michael Canzoneri, revealed four significant observations regarding the company's quality system and manufacturing practices. Firstly, the firm's complaint handling procedures were inadequate, failing to consistently evaluate events for mandatory FDA reporting, lacking necessary complainant details, and often missing sufficient information for root cause determination. Secondly, device history records did not consistently demonstrate that products were manufactured in accordance with the device master record, with manufacturing operators not accurately completing work orders per standard procedures. Thirdly, procedures for managing changes to specifications, processes, and procedures were deficient, exemplified by an operator unilaterally changing product specifications without proper Quality Control approval. Lastly, finished device acceptance procedures were inadequate, as they did not ensure a thorough review of associated device history documentation or confirmation that all master record requirements were met prior to product release. Canadian Hospital Specialties addressed one observation during the inspection and committed to correcting the remaining issues by various dates in March and June 2017 to ensure compliance with applicable regulatory requirements.

## Related Documents

- [483 - 2017-02-02](https://www.globalkeysolutions.net/records/483/canadian-hospital-specialties-ltd/86eca60b-4616-43f6-9abb-e9413bd9d403)

## Related Officers

- [Gamal A. Norton](https://www.globalkeysolutions.net/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)
- [President](https://www.globalkeysolutions.net/people/michael-canzoneri/75bda88b-27b8-4e75-abb7-e65cadccf628)

Company: https://www.globalkeysolutions.net/companies/canadian-hospital-specialties-ltd/b494a221-6e4e-4425-b128-6ad98100f0b7

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7