FDA Inspection
Rotech Healthcare Inc.d/b/a/ First Community Care of NiagaraRotech Healthcare Inc.d/b/a/ First Community Care of Niagara – FDA Inspection, Oct 15, 2010
Record Details
This FDA Inspection record concerns Rotech Healthcare Inc.d/b/a/ First Community Care of Niagara, with an inspection on October 15, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 15, 2010
- Product Type
- Drugs
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ID · 2d96d861-32ea-4c85-bee6-7e6f07ac7fe4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 684196
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Rotech Healthcare Inc.d/b/a/ First Community Care of Niagara
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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