# FDA 483 - Active Creations LLC - November 02, 2021

Source: https://www.keypedia.com/records/483/active-creations-llc/5a9f3a1c-0f33-4726-b6fe-155795eeaccf

> FDA 483 for Active Creations LLC on November 02, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Active Creations LLC
- Inspection Date: 2021-11-02
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Suite K Value Added Services LLC in Edison, NJ, revealed two significant observations related to manufacturing controls. The firm failed to validate its warehouse management system, impacting critical operations like material receiving and inventory. Additionally, equipment maintenance was found inadequate, with damaged gaskets on manufacturing vessels posing a contamination risk to drug products.

## Related Officers

- [Adetutu M. Gidado](https://www.keypedia.com/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)

Company: https://www.keypedia.com/companies/active-creations-llc/ee6ed0c9-54c4-4309-b6fb-fc5b4266799e

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248