# FDA 483 - ImprimisRx NJ - August 05, 2022

Source: https://www.keypedia.com/records/483/imprimisrx-nj/b9ad2c5d-3f6f-4705-971e-001ead002111

> FDA 483 for ImprimisRx NJ on August 05, 2022. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: ImprimisRx NJ
- Inspection Date: 2022-08-05
- Product Type: Drugs
- Office Name: New Jersey District Office
- Summary: This FDA Form 483 documents observations from an inspection of a pharmaceutical manufacturing facility. The inspection identified several deficiencies related to aseptic processing, environmental control, cleaning processes, and product quality.

Key observations include:
*   **Aseptic Processing Area Contamination:** Visibly dirty equipment and surfaces were found in ISO 5 classified aseptic processing areas.
*   **Personnel Practices:** Personnel did not disinfect and change gloves frequently enough to prevent contamination.
*   **Material Transfer:** Materials and supplies were not disinfected prior to entering aseptic processing areas.
*   **Air Quality Control:** The facility allowed the influx of poor quality air into higher classified areas.
*   **Environmental Cleanliness:** Segregated production areas surrounding the ISO 5 aseptic processing area had dust-collecting overhangs that were not adequately and frequently cleaned. Non-microbial contamination was also observed in the production area.
*   **Cleaning Validation:** There is no assurance that the cleaning process effectively removes product and cleaning agent residue from reusable glassware and utensils used in non-sterile production areas.
*   **Product Quality:** The firm released drug product where the strength differed from, or its purity or quality fell below, what was purported or represented.
*   **Area Certification:** ISO 5 classified areas were not certified under dynamic conditions.

These observations indicate significant issues with the facility's quality system, manufacturing controls, and environmental monitoring, potentially impacting drug product sterility, purity, and overall

## Related Documents

- [OTHER_CORRESPONDENCE - 2017-06-19](https://www.keypedia.com/records/other_correspondence/imprimisrx-nj/cac77b51-1b4c-4dd9-9e34-f7f958d1087e)
- [483 - 2013-08-19](https://www.keypedia.com/records/483/imprimisrx-nj/60bd6b80-096a-463f-ac9c-fd536416bd2c)
- [WARNING_LETTER - 2013-08-19](https://www.keypedia.com/records/warning_letter/imprimisrx-nj/3685214b-c1b0-4a1b-9edb-0036f1df522d)
- [WARNING_LETTER - 2022-08-05](https://www.keypedia.com/records/warning_letter/imprimisrx-nj/5cc5aba9-596e-4551-9c9b-e341f4d45be9)
- [483_RESPONSE - 2013-08-19](https://www.keypedia.com/records/483_response/imprimisrx-nj/e42e4f5d-0a10-496c-a641-cf2fe129c440)

## Related Officers

- [ Drug Investigator](https://www.keypedia.com/people/tekalign-wondimu/3b80e5c8-4062-4e1d-8ddd-b1afa2616dec)
- [Sena G. Dissmeyer](https://www.keypedia.com/people/sena-g-dissmeyer/4dbb1255-95e4-402b-8bb3-75c4f7940c13)
- [Investigator](https://www.keypedia.com/people/amy-n-chen/c3515e0e-dbb9-4540-bd2b-82c06d00dd42)

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