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FDA Inspection
•Detroit Oxygen & Medical Equipment Co.•January 12, 2012

Detroit Oxygen & Medical Equipment Co. – FDA Inspection, Jan 12, 2012

Record Details

This FDA Inspection record concerns Detroit Oxygen & Medical Equipment Co., with an inspection on January 12, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Detroit Oxygen & Medical Equipment Co.
Inspection Date
January 12, 2012
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 1a559e16-df2b-4392-a16a-b611b7330d86

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
763084
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

2
  1. 21 CFR 211.68(a)Written calibration / inspection records not kept
  2. 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Detroit Oxygen & Medical Equipment Co.

1
DateClassificationOfficeProject area
December 3, 2014NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Detroit Oxygen & Medical Equipment Co.
  • FDA Inspection 905549 - 2014-12-03

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