FDA Inspection
PALMETTO ISOTOPES, LLCPALMETTO ISOTOPES, LLC – FDA Inspection, Feb 28, 2025
Record Details
This FDA Inspection record concerns PALMETTO ISOTOPES, LLC, with an inspection on February 28, 2025, issued by the Atlanta District Office, covering human drugs.
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ID · 2afc605a-5ed6-4e38-ba95-67b5bb40874a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1263852
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- FD&C Act 501(a)(2)(A)Production areas, difficult to clean/particle generating
- FD&C Act 501(a)(2)(A)Inadequate smoke studies
- FD&C Act 501(a)(2)(A)Personnel in aseptic processing, non-sterile gloves
- FD&C Act 501(a)(2)(A)Lack of/inadequate, environmental monitoring
- FD&C Act 501(a)(2)(A)Media fills, failure
- FD&C Act 501(a)(2)(A)Sporicidal agent, ISO 5/classified areas
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