# FDA 483 - Bell-More Labs, Inc. - April 03, 2024

Source: https://www.keypedia.com/records/483/bell-more-labs-inc/3085b1ef-9ad5-4a1c-a9d2-b2731275aeb2

> FDA 483 for Bell-More Labs, Inc. on April 03, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bell-More Labs, Inc.
- Inspection Date: 2024-04-03
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: Bell-More Labs, Inc., a sterile drug manufacturer in Hampstead, MD, was cited for significant deficiencies in its aseptic processing and quality control systems. The inspection revealed widespread issues including inadequate sterility assurance for drug product stoppers, unvalidated sterilization processes, ineffective investigations into microbial contamination and particulate excursions, and critical failures in environmental monitoring and facility maintenance. These conditions raise serious concerns about the sterility and quality of both human and veterinary drug products manufactured at the facility.

## Related Documents

- [483 - 2021-06-07](https://www.keypedia.com/records/483/bell-more-labs-inc/32996a1a-9ceb-486d-b1f7-2b59bfadbacf)

## Related Officers

- [Andrew O. Ejiofor](https://www.keypedia.com/people/andrew-o-ejiofor/6f256c75-79a4-41a0-a51b-480d5db8f3da)
- [Advisor](https://www.keypedia.com/people/frederick-razzaghi/7346f6ec-1d9a-4ad3-abde-0497dcd9c8b5)
- [Investigator](https://www.keypedia.com/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)

Company: https://www.keypedia.com/companies/bell-more-labs-inc/bad31242-110f-44d2-b482-63e10bf40dcb

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