# FDA 483 - Nephron Sterile Compounding Center LLC - April 20, 2022

Source: https://www.keypedia.com/records/483/nephron-sterile-compounding-center-llc/911b55c8-9629-4742-bd1c-4f0b158a4fe6

> FDA 483 for Nephron Sterile Compounding Center LLC on April 20, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nephron Sterile Compounding Center LLC
- Inspection Date: 2022-04-20
- Product Type: Drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Nephron Sterile Compounding Center LLC, an outsourcing facility in West Columbia, SC, was conducted from March 28, 2022, to April 20, 2022. The inspection, led by Margaret M Annes, CSO, and others, identified several observations.

**Key Observations:**

1.  **Failure to Thoroughly Review Discrepancies:** The firm failed to investigate the majority of environmental and personnel monitoring excursions in the ISO 5 environment. From January 1, 2021, to March 31, 2022, approximately 1686 excursions occurred, including 240 related to critical personnel and 51 related to viable air/surface samples in the ISO 5 hood, with 48 of these 51 not investigated.

2.  **Deficient Environmental Monitoring System:**
    *   No documentation justified action levels for personnel and environmental monitoring. Investigations were not performed for most excursions below action levels, except for objectionable organisms.
    *   A desiccation study for viable air sampling plates lacked a written/approved protocol and failed to demonstrate microbial growth support after the determined time limit.

3.  **Inadequate Sterility Test Procedures:** Test procedures for sterility were not written and followed.

4.  **Inadequate Aseptic Process Validation:**
    *   Media fills did not simulate all stressful conditions, such

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## Related Officers

- [Brandon C. Heitmeier](https://www.keypedia.com/people/brandon-c-heitmeier/09e1b64b-01de-4f8b-819a-1179d8b4c0c1)
- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)
- [Kemejumaka N. Opara](https://www.keypedia.com/people/kemejumaka-n-opara/3f9219f1-13ab-49d7-99fe-5a683e351cd4)
- [Investigator](https://www.keypedia.com/people/desiree-d-clark/54497a7a-2f7c-47b6-8251-6acd2a9e0db5)
- [Investigator](https://www.keypedia.com/people/demario-l-walls/c69c4c87-f001-45ab-8d7b-b45c60226ff1)

Company: https://www.keypedia.com/companies/nephron-sterile-compounding-center-llc/b9848542-bf88-4696-80c3-5fc545b76a92

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7