# FDA 483 - C. B. Fleet Company, Inc. - December 01, 2023

Source: https://www.globalkeysolutions.net/records/483/c-b-fleet-company-inc/b15c3f8d-57b8-4929-8f2a-32a0034bf065

> FDA 483 for C. B. Fleet Company, Inc. on December 01, 2023. 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: 2023-12-01
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: C. B. Fleet, Inc. dba Fleet Laboratories, a drug product manufacturer in Lynchburg, VA, was cited for significant deficiencies in equipment qualification, discrepancy investigations, and preventive maintenance. The inspection revealed unqualified packaging line equipment, a failure to investigate 80 complaints of drug product container leaks, and a systemic issue with overdue equipment maintenance. These issues indicate a lack of control over critical manufacturing and quality processes.

## Related Documents

- [483 - 2025-04-18](https://www.globalkeysolutions.net/records/483/c-b-fleet-company-inc/b346ea80-1194-47c2-b9fc-60ecf2929345)

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.globalkeysolutions.net/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

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

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64