# FDA 483 - Nephron Sterile Compounding Center LLC - September 25, 2024

Source: https://www.keypedia.com/records/483/nephron-sterile-compounding-center-llc/4e41a7ad-34b2-499b-a450-937730b2c4f5

> FDA 483 for Nephron Sterile Compounding Center LLC on September 25, 2024. 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: 2024-09-25
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: From September 16-25, 2024, the FDA inspected Nephron Sterile Compounding Center LLC, an outsourcing facility in West Columbia, SC, owned by Lou Wood Kennedy. The inspection revealed five observations related to production, quality, equipment, and facilities.

**Production System Deficiencies:**
*   **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products are not established.
    *   The syringe filling machine in room 282G allows exposed syringe tips to face the syringe track, potentially creating air currents that circulate particulates around the tips. Products affected include Phenylephrine HCl, Succinylcholine Chloride, Ketamine Hydrochloride, and Rocuronium Bromide injections.
    *   Comprehensive resin bioburden testing from 2022-2024 identified objectionable eukaryotic organisms (e.g., *Aspergillus*, *Penicillium*, *Cladosporium*, *Fusarium*, *Rhizopus*, *Mucor*, *Alternaria*, *Trichoderma*, *Acremonium*, *Paecilomyces*, *Bipolaris*, *Curvularia*, *Epicoccum*, *Phoma*, *Stachybotrys*, *Ulocladium*, *Wallemia*, *Chaetomium*, *Scopulariopsis*, *Geotrichum*, *Rhodotorula*, *Candida*, *Saccharomyces*, *Cryptococcus*, *Pichia*,

## Related Documents

- [483 - 2023-02-10](https://www.keypedia.com/records/483/nephron-sterile-compounding-center-llc/d8ba35dd-93fc-4c62-a6ac-6cfbcd185d5d)
- [483 - 2022-04-20](https://www.keypedia.com/records/483/nephron-sterile-compounding-center-llc/911b55c8-9629-4742-bd1c-4f0b158a4fe6)
- [483 - 2022-04-20](https://www.keypedia.com/records/483/nephron-sterile-compounding-center-llc/a1ade3d7-b938-49d1-8f6d-092e3d4e1655)
- [483 - 2019-11-15](https://www.keypedia.com/records/483/nephron-sterile-compounding-center-llc/b90a675e-bc01-45a7-8205-6917e345158d)
- [483 - 2017-04-21](https://www.keypedia.com/records/483/nephron-sterile-compounding-center-llc/5f17ae1c-a089-4536-8e06-5c61164a98cd)

## Related Officers

- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)
- [Veronica Ley Fuentes-CEO](https://www.keypedia.com/people/veronica-ley-fuentes-ceo/6425f8f7-b8fb-4c2e-bfe1-674546f03442)
- [Homero W. Aguilar](https://www.keypedia.com/people/homero-w-aguilar/fbc95655-a1a8-456f-a09a-7bc8a213a786)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c