Nephron Pharmaceuticals Corporation
Form 483 issued February 10, 2023 · West Columbia, South Carolina
- Inspection
- Nov 8, 2022 – Feb 10, 2023
- Investigators
- Clifton L. Randell· Jamie L. Port· June P. Page
- Observations
- 15
- Pages
- 26
- FEI number
- 3011158388
In short: On February 10, 2023, FDA issued a Form 483 with 15 observations to Nephron Pharmaceuticals Corporation in West Columbia, South Carolina (FEI 3011158388) after an inspection that ran Nov 8, 2022 – Feb 10, 2023. The investigators were Clifton L. Randell, Jamie L. Port, June P. Page, Mary-Jeanet McGarry, Melanie M. Walker, Song Y. Lavalais and Sonya M. Edmonds. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 9 of 15 observations.
Most cited: 21 CFR 211.42 (3×) · 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Clifton L. Randell
2 documents · 2020–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in South Carolina.
The firmNephron Pharmaceuticals Corporation history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nephron Pharmaceuticals Corporation?
FDA listed 15 observations on this Form 483, mostly about facilities & equipment, quality system and production. 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 Pharmaceuticals Corporation?
Clifton L. Randell, Jamie L. Port, June P. Page, Mary-Jeanet McGarry, Melanie M. Walker, Song Y. Lavalais and Sonya M. Edmonds are named on this Form 483, for the inspection of Nov 8, 2022 – Feb 10, 2023. Each investigator has a profile showing what they cite most.
When was Nephron Pharmaceuticals Corporation inspected by FDA?
The inspection ran Nov 8, 2022 – Feb 10, 2023, and the Form 483 is dated February 10, 2023.
How do I get the full Form 483 for Nephron Pharmaceuticals Corporation?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.