Nephron SC Inc.
Form 483 issued April 20, 2022 · West Columbia, South Carolina
- Inspection
- Mar 28 – Apr 20, 2022
- Investigators
- Demario L. Walls· Desiree D. Clark· Margaret M. Annes
- Observations
- 3
- Pages
- 5
- FEI number
- 3010892830
In short: On April 20, 2022, FDA issued a Form 483 with 3 observations to Nephron SC Inc. in West Columbia, South Carolina (FEI 3010892830) after an inspection that ran Mar 28 – Apr 20, 2022. The investigators were Demario L. Walls, Desiree D. Clark and Margaret M. Annes. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
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 whether or not the batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 03
Aseptic processing areas are deficient regarding the system…
This inspection in context
Demario L. Walls
18 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmNephron SC Inc. 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 SC Inc.?
FDA listed 3 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 SC Inc.?
Demario L. Walls, Desiree D. Clark and Margaret M. Annes 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 SC Inc. 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 SC Inc.?
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.