FDA Inspection
Carolina Infusion, LLCCarolina Infusion, LLC – FDA Inspection, Aug 18, 2026
Record Details
This FDA Inspection record concerns Carolina Infusion, LLC, with an inspection on August 18, 2026, issued by the Atlanta District Office, covering human drugs.
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ID · 887a2c6a-e8c9-4539-b3a6-f9d17c0d01e6
Inspection Facts
- Inspection number
- 1331500
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- FDCA 501(a)(2)(A)Beta-lactam, hazardous, highly potent drugs, prevention of cross-contamination
- FDCA 501(a)(2)(A)Cleanroom/ISO 5, contain dust
- FDCA 501(a)(2)(A)Flow of personnel and materials, facility
- FDCA 501(a)(2)(A)Inadequate smoke studies
- FDCA 501(a)(2)(A)Lack of/inadequate, environmental monitoring
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Other FDA inspections of Carolina Infusion, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2025 | OAI | Atlanta District Office | Drug Quality Assurance |
| August 12, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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