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, May 15, 2015
Record Details
This FDA Inspection record concerns Rotech Healthcare Inc.d/b/a/ First Community Care of Niagara, with an inspection on May 15, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 15, 2015
- Product Type
- Drugs
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ID · 4168350f-073a-4f0e-9dfa-675ea7ef20f1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 936596
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.160(b)(4)Written calibration procedures
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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 |
|---|---|---|---|
| October 15, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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