FDA Inspection
New Vitalis Pharmacy LLCNew Vitalis Pharmacy LLC – FDA Inspection, Aug 27, 2021
Record Details
This FDA Inspection record concerns New Vitalis Pharmacy LLC, with an inspection on August 27, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- New Vitalis Pharmacy LLC
- Inspection Date
- August 27, 2021
- Product Type
- Drugs
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ID · 6dfdfe10-22c7-40d4-8493-8c49133431d4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1149996
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- Unsealed HEPA filter, perimeter
- Non-microbial contamination, production area
- First pass air blockage, open unit with sterile product
- Personnel habits, contamination
- Improper gowning, contamination
- Vermin, adjacent area
- Hazardous drugs, prevention of cross-contamination
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Other FDA inspections of New Vitalis Pharmacy LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 5, 2023 | OAI | Drug Quality Assurance | |
| September 7, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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