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FDA Inspection
•Goetze-Niemer Co Inc•March 19, 2014

Goetze-Niemer Co Inc – FDA Inspection, Mar 19, 2014

Record Details

This FDA Inspection record concerns Goetze-Niemer Co Inc, with an inspection on March 19, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Goetze-Niemer Co Inc
Inspection Date
March 19, 2014
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · f2752d20-90b9-4cbf-8ff4-600639736e87

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
870748
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

3
  1. 21 CFR 1271.260(e)Temperature limits
  2. 21 CFR 1271.320(a)Procedures re complaints
  3. 21 CFR 1271.200(c)Calibration procedures and schedules (general)

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Goetze-Niemer Co Inc

3
DateClassificationOfficeProject area
February 5, 2020NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
March 8, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
December 14, 2015VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Goetze-Niemer Co Inc
  • FDA Inspection 1119118 - 2020-02-05
  • FDA Inspection 1044414 - 2018-03-08
  • FDA Inspection 952168 - 2015-12-14

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