# Nephron Sterile Compounding Center LLC – FDA 483, Apr 20, 2022

Source: https://www.keypedia.com/records/483/nephron-sterile-compounding-center-llc/a1ade3d7-b938-49d1-8f6d-092e3d4e1655

> 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: Nephron Sterile Compounding Center LLC in West Columbia, SC, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate investigations into environmental and personnel monitoring excursions, microbiology lab issues, and stability failures. Additionally, the firm failed to properly validate aseptic processes, maintain required records, and ensure proper verification in laboratory testing, while also compounding unapproved bulk drug substances.

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- [483 - 2018-04-20](https://www.keypedia.com/records/483/nephron-sterile-compounding-center-llc/87e75caa-7a10-4c1c-8ee6-ea6ab6611356) — date: April 20, 2018
- [483 - 2017-04-21](https://www.keypedia.com/records/483/nephron-sterile-compounding-center-llc/5f17ae1c-a089-4536-8e06-5c61164a98cd) — date: April 21, 2017

## Related Officers

- [Brandon C. Heitmeier](https://www.keypedia.com/people/brandon-c-heitmeier/09e1b64b-01de-4f8b-819a-1179d8b4c0c1)
- [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)
- [Saundra A. Munroe](https://www.keypedia.com/people/saundra-a-munroe/8e9b8973-5ac4-4a2a-ab26-1618c0e434e7)
- [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