Nephron Pharmaceuticals Corporation
Form 483 issued April 21, 2017 · West Columbia, South Carolina
- Inspection
- Apr 17 – Apr 21, 2017
- Investigators
- Bonita S. Chester· Diane P. Goyette· Rachael L. Cook
- Observations
- 4
- Pages
- 3
- FEI number
- 3011158388
In short: On April 21, 2017, FDA issued a Form 483 with 4 observations to Nephron Pharmaceuticals Corporation in West Columbia, South Carolina (FEI 3011158388) after an inspection that ran Apr 17 – Apr 21, 2017. The investigators were Bonita S. Chester, Diane P. Goyette and Rachael L. Cook. Most observations concern production and laboratory controls.
At a glance
Observations span 3 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 0421 CFR 201.1
The container labels of your outsourcing facility's…
This inspection in context
Bonita S. Chester
17 documents · 2013–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nephron Pharmaceuticals Corporation?
FDA listed 4 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Nephron Pharmaceuticals Corporation?
Bonita S. Chester, Diane P. Goyette and Rachael L. Cook are named on this Form 483, for the inspection of Apr 17 – Apr 21, 2017. Each investigator has a profile showing what they cite most.
When was Nephron Pharmaceuticals Corporation inspected by FDA?
The inspection ran Apr 17 – Apr 21, 2017, and the Form 483 is dated April 21, 2017.
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.