FDA Inspection
PharmScript, LLCPharmScript, LLC – FDA Inspection, Aug 7, 2018
Record Details
This FDA Inspection record concerns PharmScript, LLC, with an inspection on August 7, 2018, issued by the New Jersey District Office, covering human drugs.
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ID · f10fa155-5082-40ca-a52f-0285f0e58045
Inspection Facts
- Inspection number
- 1061337
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- FDCA 501(a)(2)(A)Beta-lactam drugs, inadequate sanitation
- FDCA 501(a)(2)(A)Exposure of personnel in aspectic processing
- FDCA 501(a)(2)(A)Inadequate sporicidal agents, cleanroom and ISO 5 area
- FDCA 501(a)(2)(A)Personnel contact outside ISO 5 area
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Other FDA inspections of PharmScript, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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