Carolina Infusion
Form 483 issued August 12, 2022 · Ridgeland, South Carolina
- Inspection
- Jul 18 – Aug 12, 2022
- Investigator
- Jared P. Stevens
- Observations
- 5
- Pages
- 5
- FEI number
- 3015826782
In short: On August 12, 2022, FDA issued a Form 483 with 5 observations to Carolina Infusion in Ridgeland, South Carolina (FEI 3015826782) after an inspection that ran Jul 18 – Aug 12, 2022. The investigator was Jared P. Stevens. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and facilities & equipment account for 4 of 5 observations.
Most cited: 21 CFR 211.84 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your fnm produced diug products with materials that had not been verified to assure that they…
- 02
Your media fills were not performed under the most…
- 03
ISO-5 classified areas were not…
- 04
Inadequate pressure differentials between higher quality air rooms and lower quality air rooms were observed. differential…
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 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 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Carolina Infusion?
FDA listed 5 observations on this Form 483, mostly about materials, facilities & equipment and production. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Carolina Infusion?
Jared P. Stevens is named on this Form 483, for the inspection of Jul 18 – Aug 12, 2022. Each investigator has a profile showing what they cite most.
When was Carolina Infusion inspected by FDA?
The inspection ran Jul 18 – Aug 12, 2022, and the Form 483 is dated August 12, 2022.
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.