Nephron Pharmaceuticals Corporation
Form 483 issued April 20, 2018 · West Columbia, South Carolina
- Inspection
- Apr 16 – Apr 20, 2018
- Investigators
- Larry K. Hampton· Seneca Toms
- Observations
- 1
- Pages
- 2
- FEI number
- 3011158388
In short: On April 20, 2018, FDA issued a Form 483 with 1 observation to Nephron Pharmaceuticals Corporation in West Columbia, South Carolina (FEI 3011158388) after an inspection that ran Apr 16 – Apr 20, 2018. The investigators were Larry K. Hampton and Seneca Toms. Most observations concern production; the most-cited regulation is 21 CFR 211.28 (personnel responsibilities).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.28 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Clothing of personnel engaged in the manufacturing of drug products is not appropriate for…
This inspection in context
Larry K. Hampton
2 documents · 2017–2018
Cites 211.192 (production record review) 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 211.28
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nephron Pharmaceuticals Corporation?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.28 (personnel responsibilities). The opening words of each observation are shown on this page.
Who inspected Nephron Pharmaceuticals Corporation?
Larry K. Hampton and Seneca Toms are named on this Form 483, for the inspection of Apr 16 – Apr 20, 2018. Each investigator has a profile showing what they cite most.
When was Nephron Pharmaceuticals Corporation inspected by FDA?
The inspection ran Apr 16 – Apr 20, 2018, and the Form 483 is dated April 20, 2018.
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.