FDA Inspection
Genesis Respiratory Services, LLCGenesis Respiratory Services, LLC – FDA Inspection, Sep 26, 2013
Record Details
This FDA Inspection record concerns Genesis Respiratory Services, LLC, with an inspection on September 26, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 26, 2013
- Product Type
- Drugs
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ID · 5b723676-c4b1-4e00-95c4-10dba4efd193
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 849932
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
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Other FDA inspections of Genesis Respiratory Services, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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