Nephron Pharmaceuticals Corporation
Form 483 issued April 20, 2022 · West Columbia, South Carolina
- Inspection
- Mar 28 – Apr 20, 2022
- Investigators
- Brandon C. Heitmeier· Demario L. Walls· Desiree D. Clark
- Observations
- 7
- Pages
- 8
- FEI number
- 3011158388
In short: On April 20, 2022, FDA issued a Form 483 with 7 observations to Nephron Pharmaceuticals Corporation in West Columbia, South Carolina (FEI 3011158388) after an inspection that ran Mar 28 – Apr 20, 2022. The investigators were Brandon C. Heitmeier, Demario L. Walls, Desiree D. Clark, Kemejumaka N. Opara, Margaret M. Annes and Saundrea A. Munroe. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Test procedures relative to appropriate laboratory testing for sterility are…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Brandon C. Heitmeier
12 documents · 2009–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Tennessee.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nephron Pharmaceuticals Corporation?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Nephron Pharmaceuticals Corporation?
Brandon C. Heitmeier, Demario L. Walls, Desiree D. Clark, Kemejumaka N. Opara, Margaret M. Annes and Saundrea A. Munroe are named on this Form 483, for the inspection of Mar 28 – Apr 20, 2022. Each investigator has a profile showing what they cite most.
When was Nephron Pharmaceuticals Corporation inspected by FDA?
The inspection ran Mar 28 – Apr 20, 2022, and the Form 483 is dated April 20, 2022.
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.