FDA Inspection
empower clinic services, llc, empower clinic services, llc, – FDA Inspection, Dec 1, 2023
Record Details
This FDA Inspection record concerns empower clinic services, llc, , with an inspection on December 1, 2023, covering drugs.
- Inspection Date
- December 1, 2023
- Product Type
- Drugs
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ID · af195b0a-535b-4081-a084-6e873f993831
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1223951
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- FDCA 501(a)(2)(A)Biological indicators, not used
- FDCA 501(a)(2)(A)Components/containers/materials, endotoxin contamination
- FDCA 501(a)(2)(A)Failure/inadequate, filter integrity testing
- FDCA 501(a)(2)(A)Failure to clean and disinfect/sterilize equipment, ISO 5 area
- FDCA 501(a)(2)(A)Lack of/inadequate, environmental monitoring
- FDCA 501(a)(2)(A)Personnel, blocked or disrupted first air
- FDCA 501(a)(2)(A)Personnel infrequently, changed/sanitized gloves
- FDCA 501(a)(2)(A)Use of non-pharmaceutical, ingredients/processing aides
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Other FDA inspections of empower clinic services, llc,
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2025 | Not classified | Dallas District Office | Drug Quality Assurance |
| October 4, 2024 | OAI | Dallas District Office | Drug Quality Assurance |
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