FDA Inspection
Seattle Children's HospitalSeattle Children's Hospital – FDA Inspection, Mar 25, 2011
Record Details
This FDA Inspection record concerns Seattle Children's Hospital, with an inspection on March 25, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Seattle Children's Hospital
- Inspection Date
- March 25, 2011
- Product Type
- Drugs
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ID · 2e5b2f88-30e8-4946-b7f6-ed2c849cd13f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 714713
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.100(a)Absence of Written Procedures
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