FDA Inspection
Florida Palliative Equipment L.L.C. dba Accent MedicalFlorida Palliative Equipment L.L.C. dba Accent Medical – FDA Inspection, Oct 21, 2011
Record Details
This FDA Inspection record concerns Florida Palliative Equipment L.L.C. dba Accent Medical, with an inspection on October 21, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 21, 2011
- Product Type
- Drugs
View Company Profile
ID · 66d4efed-7c20-4da8-bce2-3bd96f743013
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 750099
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.198(b)Complaint File Location
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.82(b)Quarantine Storage of Components
- 21 CFR 211.125(b)Examination of issued labels
- 21 CFR 211.122(c)Records fail to include
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
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Other FDA inspections of Florida Palliative Equipment L.L.C. dba Accent Medical
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 19, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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