FDA Inspection
Carolina Infusion, LLCCarolina Infusion, LLC – FDA Inspection, Jan 24, 2025
Record Details
This FDA Inspection record concerns Carolina Infusion, LLC, with an inspection on January 24, 2025, issued by the Atlanta District Office, covering human drugs.
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ID · 96d68856-6f57-473b-aa7f-e05206fdbce5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1259930
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- FD&C Act 501(a)(2)(A)Media fills, failure
- FD&C Act 501(a)(2)(A)Exposed to lower quality air/ISO 5
- FD&C Act 501(a)(2)(A)Inadequate smoke studies
- FD&C Act 501(a)(2)(A)Lack of disinfection, equipment/supplies from lower to higher quality air
- FD&C Act 501(a)(2)(A)Lack of/inadequate, environmental monitoring
- FD&C Act 501(a)(2)(A)Beta-lactam, hazardous, highly potent drugs, prevention of cross-contamination
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Other FDA inspections of Carolina Infusion, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 18, 2026 | Not classified | Atlanta District Office | Drug Quality Assurance |
| August 12, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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