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

Source: https://www.keypedia.com/records/483/nephron-sterile-compounding-center-llc/1b60a5fc-fddf-41aa-b615-00e487fc641a

> 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: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Nephron Sterile Compounding Center LLC in West Columbia, SC, revealed significant deficiencies in aseptic processing and quality control. Observations included inadequate procedures to prevent microbiological contamination, insufficient environmental monitoring, and failures in investigating product discrepancies and complaints. The facility also lacked proper differential air pressure monitoring and maintained uncleanable surfaces in aseptic areas, indicating a high risk to product sterility and patient safety.

## Related Documents

- [483 - 2024-09-25](https://www.keypedia.com/records/483/nephron-sterile-compounding-center-llc/4e41a7ad-34b2-499b-a450-937730b2c4f5)
- [483 - 2023-02-10](https://www.keypedia.com/records/483/nephron-sterile-compounding-center-llc/d8ba35dd-93fc-4c62-a6ac-6cfbcd185d5d)
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- [483 - 2019-11-15](https://www.keypedia.com/records/483/nephron-sterile-compounding-center-llc/b90a675e-bc01-45a7-8205-6917e345158d)

## Related Officers

- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)
- [Pharmaceutical Specialist/ Investigator ](https://www.keypedia.com/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)
- [Romero W. Aguilar](https://www.keypedia.com/people/romero-w-aguilar/9dcd4c6f-693e-4a5f-b464-76357dece600)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6