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FDA Inspection
•Johnston Memorial Hospital, Inc.•June 21, 2013

Johnston Memorial Hospital, Inc. – FDA Inspection, Jun 21, 2013

Record Details

This FDA Inspection record concerns Johnston Memorial Hospital, Inc., with an inspection on June 21, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Johnston Memorial Hospital, Inc.
Inspection Date
June 21, 2013
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 263e9ab4-d41c-48c8-8689-f5fa15fbb55b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
834824
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

6
  1. 21 CFR 606.100(c)Record review prior to release
  2. 21 CFR 606.60(a)Maintain and clean equipment
  3. 21 CFR 606.100(c)Thorough investigations
  4. 21 CFR 640.11(a)General requirements - storage
  5. 21 CFR 211.68(b)input/output verification
  6. 21 CFR 606.160(a)(1)Concurrent documentation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Johnston Memorial Hospital, Inc.

6
DateClassificationOfficeProject area
April 10, 2025NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 8, 2022NAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
January 10, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
December 4, 2015VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 24, 2011NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 6 other inspections on the company page
Other documents for Johnston Memorial Hospital, Inc.
  • FDA Inspection 1267434 - 2025-04-10
  • FDA Inspection 1172616 - 2022-06-08
  • FDA Inspection 1040707 - 2018-01-10
  • FDA Inspection 952022 - 2015-12-04
  • FDA Inspection 715812 - 2011-03-24

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