# FDA 483 - Federal Package Network, Inc - December 13, 2024

Source: https://www.globalkeysolutions.net/records/483/federal-package-network-inc/33d9da0a-dd58-4ab8-95b9-aa844eb288ed

> FDA 483 for Federal Package Network, Inc on December 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Federal Package Network, Inc
- Inspection Date: 2024-12-13
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Federal Package Network, Inc. in Chanhassen, MN, a drug manufacturer, revealed significant deficiencies in their quality system. The firm was cited for inadequate laboratory controls, including unvalidated HPLC methods and poor data integrity practices, as well as failures in thoroughly investigating discrepancies and out-of-specification results. Additionally, the inspection found issues with process validation for OTC drug products and a lack of adherence to quality unit responsibilities.

## Related Documents

- [483 - 2017-02-17](https://www.globalkeysolutions.net/records/483/federal-package-network-inc/9b008f7b-a597-43cb-b967-93f4b62f46a7)

## Related Officers

- [Aerial A. Smith](https://www.globalkeysolutions.net/people/aerial-a-smith/1f2a9d0e-91b0-4e59-ace1-0527785217e1)
- [Investigator?](https://www.globalkeysolutions.net/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/eric-d-bowles/bb6c783b-0933-4231-b79e-c591cbc50104)

Company: https://www.globalkeysolutions.net/companies/federal-package-network-inc/0e898c92-44be-4e9b-8583-caf8ea643736

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