# FDA 483 - ImprimisRx NJ - April 09, 2019

Source: https://www.keypedia.com/records/483/imprimisrx-nj/d2c04a43-2dd3-4e66-b9f0-b343dd87b27a

> FDA 483 for ImprimisRx NJ on April 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ImprimisRx NJ
- Inspection Date: 2019-04-09
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of ImprimisRx in Ledgewood, NJ, identified a critical issue with the aseptic processing environment. The ISO 7 Filling Room, used for sterile ophthalmic and injectable drug products, was found to have inadequately constructed ceiling tiles that moved during cleaning, compromising aseptic conditions. This poses a risk to the sterility of manufactured drug products.

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## Related Officers

- [CSO](https://www.keypedia.com/people/nancy-f-scheraga/7ab7500d-901f-4953-95a7-4a2b22488f04)
- [investigator](https://www.keypedia.com/people/jay-wong/d58065c6-6c52-4d77-af6b-089176c778c9)

Company: https://www.keypedia.com/companies/imprimisrx-nj/4c5c7886-bcf6-4aa1-aa74-882590c33746

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