FDA Inspection
Pharmedium Services, LLCPharmedium Services, LLC – FDA Inspection, Apr 11, 2018
Record Details
This FDA Inspection record concerns Pharmedium Services, LLC, with an inspection on April 11, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6cabfb51-4d79-4709-bcb0-8aa5cb9ca2d0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1047678
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.180(f)Responsible firm officials notified in writing
- 21 CFR 211.180(d)Reader/Photocopy equipment not made available
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Pharmedium Services, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 4, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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