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

Source: https://www.keypedia.com/records/483/canadian-hospital-specialties-ltd/86eca60b-4616-43f6-9abb-e9413bd9d403

> FDA 483 for Canadian Hospital Specialties Ltd. on February 02, 2017. Product: device. 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: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA Form 483 was issued to Canadian Hospital Specialties in Oakville, a medical device manufacturer, following an inspection. The report details four observations primarily concerning deficiencies in the firm's quality system. Key issues include inadequate complaint handling procedures, inconsistent device history records, unapproved changes to manufacturing specifications, and insufficient finished device acceptance activities prior to product release.

## Related Documents

- [483 - 2017-02-02](https://www.keypedia.com/records/483/canadian-hospital-specialties-ltd/1b8a0e1a-7f66-4f56-971a-a4ba947e02dc)

## Related Officers

- [Gamal A. Norton](https://www.keypedia.com/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd