Atlas

FDA-Inspected Site

Nephron SC, LLC

5 FDA inspections are on record for Nephron SC, LLC in West Columbia, United States.

483· Form 483 issued

West Columbia, United States · Last updated July 11, 2026

Overview

  • 5 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-08-22.

At a glance

Inspections

5

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
11 Aug 2025 – 22 Aug 2025Human Drugs483View 483 →
16 Sep 2024 – 25 Sep 2024Human Drugs483View 483 →
29 Jan 2024 – 9 Feb 2024Human Drugs483View 483 →
28 Mar 2022 – 20 Apr 2022Human DrugsWLView 483 →
3 Mar 2015 – 12 Mar 2015Human DrugsClean

Observations on record

Form 483 observations cited at this site, most recent first.

22 Aug 2025
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Simone E Pitts, Saundrea A Munroe, Kellia N Hicks, Rose L Jean-Mary

22 Aug 2025
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Simone E Pitts, Saundrea A Munroe, Kellia N Hicks, Rose L Jean-Mary

22 Aug 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Simone E Pitts, Saundrea A Munroe, Kellia N Hicks, Rose L Jean-Mary

22 Aug 2025
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Simone E Pitts, Saundrea A Munroe, Kellia N Hicks, Rose L Jean-Mary

22 Aug 2025
21 CFR 211.42(c)(10)(iii)

Air Supply

Cited by Simone E Pitts, Saundrea A Munroe, Kellia N Hicks, Rose L Jean-Mary

Investigators

FDA investigators tied to this site in the record.

Saundrea A Munroe2 insp.
Simone E Pitts1 insp.
Kellia N Hicks1 insp.
Rose L Jean-Mary1 insp.
Veronica Fuentes1 insp.
Joanne E King1 insp.
Homero W Aguilar1 insp.
Santos E Camara1 insp.
Walden H Lee1 insp.
Michael S Budziak1 insp.
David J Gomes1 insp.
Brandon C Heitmeier1 insp.
Margaret M Annes1 insp.
Desiree D Clark1 insp.
Demario L Walls1 insp.
Kemejumaka N Opara1 insp.
Bonita S Chester1 insp.
Sharna D Pratt1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations4x
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations3x
21 CFR 211.42(c)(10)(iii)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(i)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Nephron SC, LLC's 4 Form 483s

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat