Nephron SC Inc.
Form 483 issued August 22, 2025 · West Columbia, South Carolina
- Inspection
- Aug 11 – Aug 22, 2025
- Investigators
- Kellia N. Hicks· Rose Jean-Mary· Saundrea A. Munroe
- Observations
- 6
- Pages
- 15
- FEI number
- 3010892830
In short: On August 22, 2025, FDA issued a Form 483 with 6 observations to Nephron SC Inc. in West Columbia, South Carolina (FEI 3010892830) after an inspection that ran Aug 11 – Aug 22, 2025. The investigators were Kellia N. Hicks, Rose Jean-Mary, Saundrea A. Munroe and Simone E. Pitts. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
- 02
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Outsourcing…
- 03
There is a failure to thoroughly review the failure of a batch or any of its…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmNephron SC Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nephron SC Inc.?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Nephron SC Inc.?
Kellia N. Hicks, Rose Jean-Mary, Saundrea A. Munroe and Simone E. Pitts are named on this Form 483, for the inspection of Aug 11 – Aug 22, 2025. Each investigator has a profile showing what they cite most.
When was Nephron SC Inc. inspected by FDA?
The inspection ran Aug 11 – Aug 22, 2025, and the Form 483 is dated August 22, 2025.
How do I get the full Form 483 for Nephron SC Inc.?
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