Nephron Pharmaceuticals Corporation
Form 483 issued November 15, 2019 · West Columbia, South Carolina
- Inspection
- Nov 15, 2019
- Investigators
- Jared P. Stevens· Jessica L. Pressley· Seneca Toms
- Observations
- 9
- Pages
- 8
- FEI number
- 3011158388
In short: On November 15, 2019, FDA issued a Form 483 with 9 observations to Nephron Pharmaceuticals Corporation in West Columbia, South Carolina (FEI 3011158388) after an inspection that ran Nov 15, 2019. The investigators were Jared P. Stevens, Jessica L. Pressley and Seneca Toms. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 7 of 9 observations.
Most cited: 21 CFR 211.42 (3×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Test procedures relative to appropriate laboratory testing for sterility are…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Written procedures for sampling and testing plans are not followed…
This inspection in context
Jared P. Stevens
15 documents · 2017–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) 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 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls 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?
Jared P. Stevens, Jessica L. Pressley and Seneca Toms are named on this Form 483, for the inspection of Nov 15, 2019. Each investigator has a profile showing what they cite most.
When was Nephron Pharmaceuticals Corporation inspected by FDA?
The inspection ran Nov 15, 2019, and the Form 483 is dated November 15, 2019.
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.