FDA Inspection
Kaiser Foundation HospitalsKaiser Foundation Hospitals – FDA Inspection, Oct 27, 2016
Record Details
This FDA Inspection record concerns Kaiser Foundation Hospitals, with an inspection on October 27, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Ashar P. Parikh
- James C. Lee (Issuing Officer)
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ID · e64f290f-e96b-4fcc-9d29-c1220c78d14f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 993649
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.84(d)(3)Establish reliability of supplier"s C of A
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.84(d)(3)Establish reliability of supplier's C of A
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