# FDA 483 - CoRE labs, LLC - June 21, 2023

Source: https://www.keypedia.com/records/483/core-labs-llc/3ae1550f-22b6-4b61-a072-8f1ba1868867

> FDA 483 for CoRE labs, LLC on June 21, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CoRE labs, LLC
- Inspection Date: 2023-06-21
- Product Type: device
- Office Name: Denver District Office
- Summary: CORe labs, LLC, a medical device manufacturer in Englewood, CO, was cited for four observations during an FDA inspection. The firm demonstrated significant deficiencies in its quality system, specifically regarding procedures for complaint handling, design change control, management of nonconforming products, and document control. These issues indicate a systemic lack of adequate procedural establishment and documentation practices.

## Related Documents

- [WARNING_LETTER - 2012-07-25](https://www.keypedia.com/records/warning_letter/core-labs-llc/24b1c3dd-9d7a-4418-b474-977e484f4dae)
- [483 - 2019-04-11](https://www.keypedia.com/records/483/core-labs-llc/3fc3a47c-e82b-4566-a51d-5b8c7af62c18)

## Related Officers

- [investigator](https://www.keypedia.com/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

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