Carolina Infusion
Form 483 issued January 24, 2025 · Ridgeland, South Carolina
- Inspection
- Jan 14 – Jan 24, 2025
- Investigator
- Taichun Qin
- Observations
- 6
- Pages
- 6
- FEI number
- 3015826782
In short: On January 24, 2025, FDA issued a Form 483 with 6 observations to Carolina Infusion in Ridgeland, South Carolina (FEI 3015826782) after an inspection that ran Jan 14 – Jan 24, 2025. The investigator was Taichun Qin.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Materials were exposed to lower than…
- 02FDCA 501(a)(2)(A)
Inadequate routine environmental monitoring in…
- 03FDCA 501(a)(2)(A)
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case…
- 04FDCA 501(a)(2)(A)
Smoke studies were inadequately…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmCarolina Infusion history
All 4 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 Carolina Infusion?
FDA listed 6 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Carolina Infusion?
Taichun Qin is named on this Form 483, for the inspection of Jan 14 – Jan 24, 2025. Each investigator has a profile showing what they cite most.
When was Carolina Infusion inspected by FDA?
The inspection ran Jan 14 – Jan 24, 2025, and the Form 483 is dated January 24, 2025.
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.