# FDA 483 - Nephron Sc Inc - April 20, 2022

Source: https://www.keypedia.com/records/483/nephron-sc-inc/3dd6396e-f65d-40e5-9652-35c68210bbcd

> FDA 483 for Nephron Sc Inc on April 20, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nephron Sc Inc
- Inspection Date: 2022-04-20
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Nephron Sc Inc, a drug manufacturer in West Columbia, SC, was cited for significant deficiencies during an FDA inspection. The observations include failures to thoroughly investigate unexplained discrepancies, inadequate laboratory controls for sterility testing, and deficiencies in environmental monitoring within aseptic processing areas. These issues indicate a lack of robust quality control and assurance processes.

## Related Documents

- [WARNING_LETTER - 2020-09-22](https://www.keypedia.com/records/warning_letter/nephron-sc-inc/528714ca-cb23-40df-ae69-431984f050f7)
- [WARNING_LETTER - 2022-04-20](https://www.keypedia.com/records/warning_letter/nephron-sc-inc/fb25266d-0c42-4d39-9684-7eafaa7ba68e)
- [483 - 2025-08-22](https://www.keypedia.com/records/483/nephron-sc-inc/138bf3dc-807d-445f-be48-21d4172245a5)

## 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)
- [Investigator](https://www.keypedia.com/people/desiree-d-clark/54497a7a-2f7c-47b6-8251-6acd2a9e0db5)
- [Demaimake N Opara](https://www.keypedia.com/people/demaimake-n-opara/7eca87fd-0b75-4ca4-937d-e896e01e5f37)
- [Investigator](https://www.keypedia.com/people/demario-l-walls/c69c4c87-f001-45ab-8d7b-b45c60226ff1)

Company: https://www.keypedia.com/companies/nephron-sc-inc/2dadfd52-37b7-4da6-9885-864d470c1b18

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