Carolina Infusion
Form 483 issued August 18, 2026 · Ridgeland, South Carolina
- Inspection
- Aug 5 – Aug 18, 2026
- Investigators
- Joanne E. King· Roger F. Zabinski
- Observations
- 10
- Pages
- 8
- FEI number
- 3015826782
In short: On August 18, 2026, FDA issued a Form 483 with 10 observations to Carolina Infusion in Ridgeland, South Carolina (FEI 3015826782) after an inspection that ran Aug 5 – Aug 18, 2026. The investigators were Joanne E. King and Roger F. Zabinski. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
6 of 10 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (5×) · 211.113 (5×)
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 lack of HEPA-filtered air and an inadequate HEPA filter coverage or airflow over…
- 02
The Cleanroom areas contain dust-collecting overhangs without…
- 03
Inadequate I (6) (4) I on ro) (4) used…
- 04
Your firm released drug product in which the strength differs from, or its purity or quality…
This inspection in context
Joanne E. King
34 documents · 2013–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmCarolina Infusion history
All 4 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 Carolina Infusion?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Carolina Infusion?
Joanne E. King and Roger F. Zabinski are named on this Form 483, for the inspection of Aug 5 – Aug 18, 2026. Each investigator has a profile showing what they cite most.
When was Carolina Infusion inspected by FDA?
The inspection ran Aug 5 – Aug 18, 2026, and the Form 483 is dated August 18, 2026.
How do I get the full Form 483 for Carolina Infusion?
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.