FDA Inspection
Banner Home Medical EquipmentBanner Home Medical Equipment – FDA Inspection, Dec 18, 2009
Record Details
This FDA Inspection record concerns Banner Home Medical Equipment, with an inspection on December 18, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 18, 2009
- Product Type
- Biologics
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ID · c5aede45-dae7-4568-b60e-1f105ac06461
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 636432
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)(21)Donor notification
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Banner Home Medical Equipment
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 27, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 10, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Banner Home Medical Equipment
- FDA Inspection 1034530 - 2017-11-27
- FDA Inspection 754220 - 2011-11-10
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