# FDA 483 - Cook Incorporated - September 14, 2021

Source: https://www.globalkeysolutions.net/records/483/cook-incorporated/37ca8744-80b9-4dd7-9b26-f5e9c4a093a3

> FDA 483 for Cook Incorporated on September 14, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cook Incorporated
- Inspection Date: 2021-09-14
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Cook Inc. in Bloomington, IN, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for monitoring packaging seal integrity, leading to numerous complaints and nonconformances. Additionally, procedures for managing changes to specifications and procedures were inadequate, resulting in the continued use of discontinued manufacturing materials and a lack of investigation into potential widespread issues.

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- [483 - 2025-06-04](https://www.globalkeysolutions.net/records/483/cook-incorporated/88a92463-8143-48cd-bc31-9e51e9dc8351)

## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/joseph-r-strelnik/1fb7d50e-abf2-45ef-85a8-71c61b33e42d)

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

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