FDA Inspection
Community Health Network - Berlin Memorial HospitalCommunity Health Network - Berlin Memorial Hospital – FDA Inspection, Jun 25, 2010
Record Details
This FDA Inspection record concerns Community Health Network - Berlin Memorial Hospital, with an inspection on June 25, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 25, 2010
- Product Type
- Biologics
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ID · a5cac9fc-4dc8-402f-9258-4c7476f29dc9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 668236
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 640.3(b)(3)Qualifications of donor - hemoglobin
- 21 CFR 640.3(a)Donor suitability by means of medical history
- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 606.100(b)(20)Donor deferral
- 21 CFR 606.100(b)(1)Donor criteria
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Community Health Network - Berlin Memorial Hospital
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 19, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 19, 2008 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Community Health Network - Berlin Memorial Hospital
- FDA Inspection 765669 - 2012-01-19
- FDA Inspection 547558 - 2008-11-19
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