# FDA 483 - Cook Medical Incorporated - August 23, 2018

Source: https://www.globalkeysolutions.net/records/483/cook-medical-incorporated/8c540ec8-886a-4cd6-b6da-36dd6ad057df

> FDA 483 for Cook Medical Incorporated on August 23, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cook Medical Incorporated
- Inspection Date: 2018-08-23
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Cook Medical Incorporated in Bloomington, IN, an initial importer and contract manufacturer, revealed two significant observations. The firm failed to adequately establish procedures for corrective and preventive action, specifically regarding the objective verification of CAPA effectiveness. Additionally, the inspection found that potential consultants were not evaluated based on specified requirements, leading to an unqualified individual serving as a CAPA coach.

## Related Officers

- [Debara R. Reese](https://www.globalkeysolutions.net/people/debara-r-reese/277a8fbb-ba4d-4402-be08-16d7977685db)

Company: https://www.globalkeysolutions.net/companies/cook-medical-incorporated/2eda7f24-395c-4953-a345-cc3f511c00f2

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0