# FDA 483 - Noble Pharma, LLC - March 06, 2025

Source: https://www.keypedia.com/records/483/noble-pharma-llc/c04e1180-5007-41e7-b4e4-bfa5b00c9d91

> FDA 483 for Noble Pharma, LLC on March 06, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Noble Pharma, LLC
- Inspection Date: 2025-03-06
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Noble Pharma LLC, a drug manufacturer in Menomonie, WI, was cited with three observations during an FDA inspection. The firm failed to adequately validate equipment and processes for drug manufacturing, lacked proper facility configuration to prevent contamination, and had deficient controls over computer systems, including the use of a default log-on. These issues indicate significant concerns regarding GMP compliance and data integrity.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/noble-pharma-llc/bc71bd7c-3765-4391-beed-b399aece1c1f)
- [483 - 2025-08-22](https://www.keypedia.com/records/483/noble-pharma-llc/ecb7beef-f833-48b1-9251-cdd991f47a54)

## Related Officers

- [Lori B. Wikstrom](https://www.keypedia.com/people/lori-b-wikstrom/19d938f7-4a5d-42b9-b2d1-e92cdb63bb0d)
- [Aerial A. Smith](https://www.keypedia.com/people/aerial-a-smith/1f2a9d0e-91b0-4e59-ace1-0527785217e1)

Company: https://www.keypedia.com/companies/noble-pharma-llc/7fd1f37f-ba04-49a3-a115-ad7110e9f8a5

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