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FDA Inspection
•General Hospital Corporation (The)•August 12, 2011

General Hospital Corporation (The) – FDA Inspection, Aug 12, 2011

Record Details

This FDA Inspection record concerns General Hospital Corporation (The), with an inspection on August 12, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
General Hospital Corporation (The)
Inspection Date
August 12, 2011
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 6ffe281e-40f3-4965-ade4-d633b212a197

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
743401
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

2
  1. 21 CFR 606.60(a)Equipment observed, standardized, calibrated
  2. 21 CFR 640.4(f)Arm preparation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of General Hospital Corporation (The)

7
DateClassificationOfficeProject area
May 23, 2024NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
October 23, 2019NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 17, 2019Not classifiedNew England District OfficeDrug Quality Assurance
January 31, 2018NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
January 24, 2017NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
View all 7 other inspections on the company page
Other documents for General Hospital Corporation (The)
  • FDA Inspection 1241625 - 2024-05-23
  • FDA Inspection 1110333 - 2019-10-23
  • FDA Inspection 1094535 - 2019-06-17
  • FDA Inspection 1042063 - 2018-01-31
  • FDA Inspection 999897 - 2017-01-24

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