Nephron SC Inc.
FDA inspection history in West Columbia, South Carolina, 2020 to 2025
- 2
- Form 483s
- 2
- Warning letters
- 2
- Close-outs
Every document, by year
- Form 483
- Warning letter
- Close-out
2020: one close-out letter; 2022: two warning letters and one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–22Two warning letters, one close-out letter and one Form 483, at West Columbia, South Carolina.
- 2025One Form 483, at West Columbia, South Carolina.
- 2025The longest 483 on file: 6 observations over 15 pages at West Columbia, South Carolina.
Cited most
Across all Nephron SC observations on file
- 21 CFR 211.42(c)(10)(iii)Design and construction features3
- 21 CFR 211.192Production record review2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.160General requirements1
The complete Nephron SC file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
West Columbia, South Carolina
Two Form 483s, two warning letters and two close-out letters · 2020 to 2025 · 9 observations
Latest: Form 483, Aug 22, 2025 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-08-22 | 483 Form 483 | West Columbia, South Carolina | 6 | $99 |
| 2022-10-21 | Warning letter Warning letter | West Columbia, South Carolina | — | $99 |
| 2022-10-11 | Warning letter Warning letter | West Columbia, South Carolina | — | $99 |
| 2022-04-20 | 483 Form 483 | West Columbia, South Carolina | 3 | $99 |
| 2020-09-22 | Close-out Close-out letter | West Columbia, South Carolina | — | $99 |
| Undated | Close-out Close-out letter | West Columbia, South Carolina | — | $99 |
Investigators on these documents
Demario L. Walls (1)Desiree D. Clark (1)Kellia N. Hicks (1)Margaret M. Annes (1)Rose Jean-Mary (1)Saundrea A. Munroe (1)Simone E. Pitts (1)
FEI number 3010892830 · most recent document Aug 22, 2025
About Nephron SC Inc.
How many FDA Form 483s has Nephron SC Inc. received?
FDA Intel has 2 Form 483s on file for Nephron SC Inc.; the most recent is dated Aug 22, 2025.
When was Nephron SC Inc. last inspected by FDA?
The most recent FDA inspection document on file for Nephron SC Inc. is a Form 483 dated Aug 22, 2025, for the site in West Columbia, South Carolina.
What did FDA cite at Nephron SC Inc.?
The regulations cited most in the observations on file for Nephron SC Inc. are 21 CFR 211.42(c)(10)(iii) (Design and construction features), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time.
Has Nephron SC Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Nephron SC Inc.; the most recent is dated Oct 21, 2022.