FDA Inspection
Kernan,James L HospitalKernan,James L Hospital – FDA Inspection, Jun 19, 2009
Record Details
This FDA Inspection record concerns Kernan,James L Hospital, with an inspection on June 19, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Kernan,James L Hospital
- Inspection Date
- June 19, 2009
- Product Type
- Biologics
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ID · aab5ac76-01b3-4b6c-97f3-af44d363ede7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 594370
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 600.14(a)(1)Who must report - receiving information
- 21 CFR 606.170(a)Adverse reaction - Maintenance of Reports
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Kernan,James L Hospital
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Kernan,James L Hospital
- FDA Inspection 716535 - 2011-03-24
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