# FDA 483 - Cook Biotech Incorporated - February 11, 2022

Source: https://www.keypedia.com/records/483/cook-biotech-incorporated/1061f47f-e3da-4f6d-b413-fc76dae8a0cc

> FDA 483 for Cook Biotech Incorporated on February 11, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Cook Biotech Incorporated
- Inspection Date: 2022-02-11
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Parsolex GMP Center, Inc. in West Lafayette, IN, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm failed to thoroughly review unexplained discrepancies and initiate investigations for deviations, such as delayed or missing equipment entries. Additionally, procedures for equipment cleaning and maintenance were found to be deficient, lacking sufficient detail and proper documentation, and computer system controls were inadequate to ensure data integrity.

## Related Officers

- [Investigator](https://www.keypedia.com/people/muna-algharibeh/0f0dbd13-b36a-408d-8e42-4625f8de905d)
- [Michele L. Glendenning](https://www.keypedia.com/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)

Company: https://www.keypedia.com/companies/cook-biotech-incorporated/6fc0f994-686a-446b-9c69-9c1649a61ec0

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