# FDA 483 - CoRE labs, LLC - April 11, 2019

Source: https://www.keypedia.com/records/483/core-labs-llc/3fc3a47c-e82b-4566-a51d-5b8c7af62c18

> FDA 483 for CoRE labs, LLC on April 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CoRE labs, LLC
- Inspection Date: 2019-04-11
- Product Type: device
- Office Name: Denver District Office
- Summary: Cobi labs, LLC, a medical device manufacturer in Englewood, CO, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate design change procedures, unmaintained document control procedures with conflicting information, and a failure to submit required annual reports for certain products. These issues indicate a lack of robust control over product design, documentation, and regulatory compliance.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/vicky-l-cruz/282da571-56be-48f4-96c6-d590829b12c2)

Company: https://www.keypedia.com/companies/core-labs-llc/a4325eb8-9b99-4b86-9195-148bf6f525aa

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face