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FDA Inspection
•Good Samaritan Hospital•January 20, 2017

Good Samaritan Hospital – FDA Inspection, Jan 20, 2017

Record Details

This FDA Inspection record concerns Good Samaritan Hospital, with an inspection on January 20, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Good Samaritan Hospital
Inspection Date
January 20, 2017
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Amy W. Yan-Mai (Issuing Officer)
View Company Profile

ID · 6d514385-8cb4-46bd-b602-2c446b3d29fb

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1000200
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 606.160(a)(1)Person performing, test results, interpretation
  2. 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Good Samaritan Hospital

4
DateClassificationOfficeProject area
April 13, 2015VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
May 1, 2013NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 1, 2011VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 3, 2009VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Good Samaritan Hospital
  • FDA Inspection 921980 - 2015-04-13
  • FDA Inspection 830670 - 2013-05-01
  • FDA Inspection 706969 - 2011-02-01
  • FDA Inspection 604485 - 2009-09-03

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