FDA Inspection
Genesis Respiratory Services, LLCGenesis Respiratory Services, LLC – FDA Inspection, Aug 6, 2014
Record Details
This FDA Inspection record concerns Genesis Respiratory Services, LLC, with an inspection on August 6, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 6, 2014
- Product Type
- Drugs
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ID · 7989f5ef-c3a6-4509-9d2e-67a22317cfec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 890112
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Genesis Respiratory Services, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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