Nephron Pharmaceuticals Corporation
Form 483 issued September 25, 2024 · West Columbia, South Carolina
- Inspection
- Sep 25, 2024
- Investigators
- Homer O. W. Aguilar· Homero W. Agu Ilar· Homero W. Aguilar
- Observations
- 5
- Pages
- 7
- FEI number
- 3011158388
In short: On September 25, 2024, FDA issued a Form 483 with 5 observations to Nephron Pharmaceuticals Corporation in West Columbia, South Carolina (FEI 3011158388) after an inspection that ran Sep 25, 2024. The investigators were Homer O. W. Aguilar, Homero W. Agu Ilar, Homero W. Aguilar, Joa Nne E. King, Joanne E. King, Ve R. Onica Fuentes and Veronica Fuentes.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
This inspection in context
Homer O. W. Aguilar
1 document · 2024
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.
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Questions about this 483
What did FDA find at Nephron Pharmaceuticals Corporation?
FDA listed 5 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Nephron Pharmaceuticals Corporation?
Homer O. W. Aguilar, Homero W. Agu Ilar, Homero W. Aguilar, Joa Nne E. King, Joanne E. King, Ve R. Onica Fuentes and Veronica Fuentes are named on this Form 483, for the inspection of Sep 25, 2024. Each investigator has a profile showing what they cite most.
When was Nephron Pharmaceuticals Corporation inspected by FDA?
The inspection ran Sep 25, 2024, and the Form 483 is dated September 25, 2024.
How do I get the full Form 483 for Nephron Pharmaceuticals Corporation?
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