# FDA 483 - ImprimisRx NJ - July 10, 2017

Source: https://www.keypedia.com/records/483/imprimisrx-nj/557994ed-7478-4f2c-a5b6-69cb71603297

> FDA 483 for ImprimisRx NJ on July 10, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ImprimisRx NJ
- Inspection Date: 2017-07-10
- Product Type: Drugs
- Office Name: New Jersey District Office
- Summary: This FDA Form 483 document details inspectional observations made at ImprimisRx NJ, located at 1705 Route 46 West, Suite 6A, Ledgewood, NJ 07852-9720. The firm, FEI number 3003348498, is identified as a producer of sterile drugs. The inspection was conducted on May 30, 31, June 1, 2, and July 10, 2017. The report was issued to Pramod K Sharma, Ph.D, Vice President, Quality, on July 10, 2017, by Consumer Safety Officer Jose M. Cayuela.

The sole observation noted was that the ISO 5 laminar air flow hood was not certified under dynamic conditions. Specifically, the smoke study performed in a section of the ISO 5 laminar air flow hood was not conducted with all personnel and containers present. The study used (b)(4) instead of (b)(4), lacked a bulk container, and (b)(4) did not simulate product filling during the (b)(4) video, failing to assess uni-directional air flow under actual operating conditions. This indicates a deficiency in the validation and control of critical aseptic processing environments.

## Related Documents

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## Related Officers

- [Jose M. Cayuela](https://www.keypedia.com/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

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