# FDA 483 - CFB Michigan Inc - October 17, 2024

Source: https://www.keypedia.com/records/483/cfb-michigan-inc/dc92f339-a471-478c-b047-d19e50cfbdba

> FDA 483 for CFB Michigan Inc on October 17, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CFB Michigan Inc
- Inspection Date: 2024-10-17
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: CFB Michigan Inc, a manufacturer of hand sanitizer drug products in Edwardsburg, MI, was cited for significant deficiencies in its quality control unit, manufacturing processes, and laboratory controls. The inspection revealed a lack of essential procedures for component testing, stability programs, record-keeping, and process validation, indicating a severe breakdown in GMP compliance. The firm also failed to adequately test drug product components and finished products for identity and strength, and its water system was improperly designed.

## Related Officers

- [Anna M. Spiros](https://www.keypedia.com/people/anna-m-spiros/13e6a69c-d3d5-431c-9895-0df9b86691b7)
- [Investigator](https://www.keypedia.com/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)

Company: https://www.keypedia.com/companies/cfb-michigan-inc/7a681a0d-3a96-4348-949e-373c5b4ed68c

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03