FDA Inspection
New Vitalis Pharmacy LLCNew Vitalis Pharmacy LLC – FDA Inspection, Jul 5, 2023
Record Details
This FDA Inspection record concerns New Vitalis Pharmacy LLC, with an inspection on July 5, 2023, covering drugs.
- Company
- New Vitalis Pharmacy LLC
- Inspection Date
- July 5, 2023
- Product Type
- Drugs
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ID · 56b15422-4a64-42ba-acfe-f61cdbebb758
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1211023
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- FDCA 501(a)(2)(A)Facility design, influx of lesser quality air
- FDCA 501(a)(2)(A)Failure/inadequate, filter integrity testing
- FDCA 501(a)(2)(A)HEPA filters, not sealed
- FDCA 501(a)(2)(A)Inadequate smoke studies
- FDCA 501(a)(2)(A)Insufficient use, disinfectant
- FDCA 501(a)(2)(A)Media fills, failure
- FDCA 501(a)(2)(A)Non-sterile disinfecting agents, ISO 5 area/classified areas
- 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)Sporicidal agent, ISO 5/classified areas
Showing 10 of 11 citations.
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Other FDA inspections of New Vitalis Pharmacy LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 27, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 7, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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