FDA Inspection
Sharon PA Hospital Company LLCSharon PA Hospital Company LLC – FDA Inspection, Nov 23, 2016
Record Details
This FDA Inspection record concerns Sharon PA Hospital Company LLC, with an inspection on November 23, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 0b2bd1f6-def0-4bf6-a735-1ad6ce587ebf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 996154
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 606.60(a)Provide proper equipment to meet requirements
- 21 CFR 606.160(b)Required records
- 21 CFR 606.151(e)Procedures to maintain records of emergency transfusions
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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