# DNA Genotek Inc. – FDA 483, Sep 16, 2013

Source: https://www.keypedia.com/records/483/dna-genotek-inc/5a737ba8-932b-4850-af3e-3acbf0626695

> FDA 483 for DNA Genotek Inc. on September 16, 2013. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DNA Genotek Inc.
- Inspection Date: 2013-09-16
- Product Type: device
- Office Name: Foreign - CBER (Bioresearch Monitoring)
- Summary: An FDA inspection of DNA GENOTEK, INC in Ottawa, Ontario, Canada, a device manufacturer, revealed two significant observations. The firm's design planning procedures were not clearly defined, and a critical functional test for a specific product lacked a written procedure. These issues indicate deficiencies in design control and quality system documentation.

## Related Documents

- [WARNING_LETTER - 2013-09-20](https://www.keypedia.com/records/warning_letter/dna-genotek-inc/0b4c10dc-2822-4f5f-b528-69d0ec967b32) — date: September 20, 2013

## Related Officers

- [investigator](https://www.keypedia.com/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.keypedia.com/companies/dna-genotek-inc/b40c2357-0700-4b9f-ad3a-975c25987eb7

Office: https://www.keypedia.com/offices/foreign-cber-bioresearch-monitoring/f1660531-9111-4f36-bf5d-b28bf0f3b54e