# FDA 483 - C. B. Fleet Company, Inc. - April 18, 2025

Source: https://www.globalkeysolutions.net/records/483/c-b-fleet-company-inc/b346ea80-1194-47c2-b9fc-60ecf2929345

> FDA 483 for C. B. Fleet Company, Inc. on April 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: C. B. Fleet Company, Inc.
- Inspection Date: 2025-04-18
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: C. B. Fleet Company, Inc. in Lynchburg, VA, was inspected and cited for significant deficiencies in its quality control and manufacturing processes for OTC drug products. The inspection revealed a systemic failure to thoroughly investigate consumer complaints and out-of-specification results related to microbiological contamination, as well as inadequate laboratory controls and a lack of established test method specificity. Furthermore, the Quality Unit failed to implement proper risk assessments for objectionable microorganisms and ensure the effectiveness of its sanitation program.

## Related Documents

- [483 - 2023-12-01](https://www.globalkeysolutions.net/records/483/c-b-fleet-company-inc/b15c3f8d-57b8-4929-8f2a-32a0034bf065)

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.globalkeysolutions.net/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)
- [Homero W. Aguilar](https://www.globalkeysolutions.net/people/homero-w-aguilar/fbc95655-a1a8-456f-a09a-7bc8a213a786)

Company: https://www.globalkeysolutions.net/companies/c-b-fleet-company-inc/f5f5e7fa-8113-4539-bab4-a153edd37d6a

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa