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FDA Inspection
•Mennonite General Hospital, Inc.•March 26, 2012

Mennonite General Hospital, Inc. – FDA Inspection, Mar 26, 2012

Record Details

This FDA Inspection record concerns Mennonite General Hospital, Inc., with an inspection on March 26, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Mennonite General Hospital, Inc.
Inspection Date
March 26, 2012
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 20a87b36-07e9-4e3f-bc16-4f8f1ecafaee

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
774638
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

4
  1. 21 CFR 606.160(a)(1)Legibility and indelibility
  2. 21 CFR 606.160(a)(1)Person performing, test results, interpretation
  3. 21 CFR 606.100(b)(9)Written methods for investigating adverse reactions
  4. 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 Mennonite General Hospital, Inc.

7
DateClassificationOfficeProject area
September 23, 2025Not classifiedSan Juan District Office
May 30, 2023NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
November 19, 2019NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 1, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 19, 2016NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 7 other inspections on the company page
Other documents for Mennonite General Hospital, Inc.
  • FDA Inspection 1291586 - 2025-09-23
  • FDA Inspection 1210198 - 2023-05-30
  • FDA Inspection 1114056 - 2019-11-19
  • FDA Inspection 1055332 - 2018-06-01
  • FDA Inspection 967723 - 2016-01-19

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