# FDA 483 - Cook Incorporated - February 07, 2020

Source: https://www.keypedia.com/records/483/cook-incorporated/28931ff0-d54a-4c69-b7d6-a3bf62ae3cc3

> FDA 483 for Cook Incorporated on February 07, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cook Incorporated
- Inspection Date: 2020-02-07
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Cook, Inc., a medical device manufacturer in Bloomington, IN, was inspected by the FDA from January 27 to February 7, 2020. The inspection revealed significant deficiencies in their quality system, including inadequate corrective and preventive action procedures, insufficient process controls for temporary manufacturing deviations, and failures in complaint handling. These issues led to product recalls and, in one instance, a reported death associated with a delaminating Flexor sheath.

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## Related Officers

- [Debara R. Reese](https://www.keypedia.com/people/debara-r-reese/277a8fbb-ba4d-4402-be08-16d7977685db)
- [Talmane J. Fisher](https://www.keypedia.com/people/talmane-j-fisher/f69c101f-fbc7-4ca1-a6d1-1e25450c52b7)

Company: https://www.keypedia.com/companies/cook-incorporated/f23640cc-f6f5-499f-b555-3895897bfe76

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