# FDA 483 - Bell-More Labs, Inc. - June 07, 2021

Source: https://www.keypedia.com/records/483/bell-more-labs-inc/32996a1a-9ceb-486d-b1f7-2b59bfadbacf

> FDA 483 for Bell-More Labs, Inc. on June 07, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bell-More Labs, Inc.
- Inspection Date: 2021-06-07
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Bell-More Laboratories Inc. in Hampstead, MD, revealed significant deficiencies across its manufacturing and quality control operations. The firm failed to maintain adequate aseptic processing conditions, environmental monitoring, and cleaning validations. Furthermore, issues were identified with data integrity, equipment maintenance, process validations, and the overall effectiveness of the quality control unit, indicating systemic failures in ensuring drug product quality and sterility.

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## Related Officers

- [Shibshadu K Deb](https://www.keypedia.com/people/shibshadu-k-deb/1c51b2b9-a78b-49ca-a545-23567dd7a6f0)
- [Director of Investigations Branch](https://www.keypedia.com/people/nerizza-guerin/407df995-bd23-4948-82c2-e3bf8a6659b7)
- [Investigator](https://www.keypedia.com/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e