# FDA 483 - Bell International Laboratories, Inc. - June 12, 2025

Source: https://www.globalkeysolutions.net/records/483/bell-international-laboratories-inc/c32624ad-c6df-42be-b02e-64f091799f2b

> FDA 483 for Bell International Laboratories, Inc. on June 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bell International Laboratories, Inc.
- Inspection Date: 2025-06-12
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Bell International Laboratories, Inc. in Eagan, MN, was inspected by the FDA from June 2-12, 2025, for OTC drug manufacturing. The inspection revealed significant deficiencies across multiple areas, including raw material identity verification, inadequate investigation of out-of-specification results, and unvalidated manufacturing processes. Furthermore, severe data integrity issues, incomplete batch records, and a deficient supplier qualification program were observed, indicating a lack of robust quality control and adherence to GMP regulations.

## Related Documents

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- [WARNING_LETTER - 2023-09-19](https://www.globalkeysolutions.net/records/warning_letter/bell-international-laboratories-inc/3bd229d1-dcae-40bf-ade8-d48817c50c8b)

## Related Officers

- [Lori B. Wikstrom](https://www.globalkeysolutions.net/people/lori-b-wikstrom/19d938f7-4a5d-42b9-b2d1-e92cdb63bb0d)
- [Elizabeth R. Bloom](https://www.globalkeysolutions.net/people/elizabeth-r-bloom/51c7ec4e-97bb-4543-adc3-cf02d335f159)

Company: https://www.globalkeysolutions.net/companies/bell-international-laboratories-inc/05bfffdb-a90b-428e-afc2-35751b6cc668

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d