FDA Inspection
empower clinic services, llc, empower clinic services, llc, – FDA Inspection, Oct 4, 2024
Record Details
This FDA Inspection record concerns empower clinic services, llc, , with an inspection on October 4, 2024, issued by the Dallas District Office, covering human drugs.
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ID · 67f2e60a-4934-4bbf-ba08-efb067423214
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1251190
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- FD&C Act 501(a)(2)(A)Media fills, failure
- FD&C Act 501(a)(2)(A)Inadequate smoke studies
- FD&C Act 501(a)(2)(A)Beta-lactam, hazardous, highly potent drugs, prevention of cross-contamination
- FD&C Act 501(a)(2)(A)Production areas, difficult to clean/particle generating
- FD&C Act 501(a)(2)(A)Lack of, routine certification of the ISO 5
- FD&C Act 501(a)(2)(A)Failure to clean and disinfect/sterilize equipment, ISO 5 area
- FD&C Act 501(a)(2)(A)Lack of/inadequate, environmental monitoring
- FD&C Act 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 |
| December 1, 2023 | OAI | Drug Quality Assurance |
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