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FDA Inspection
•Airway Oxygen Inc.•October 14, 2011

Airway Oxygen Inc. – FDA Inspection, Oct 14, 2011

Record Details

This FDA Inspection record concerns Airway Oxygen Inc., with an inspection on October 14, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Airway Oxygen Inc.
Inspection Date
October 14, 2011
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 1d664944-f39d-4459-9093-480e886af576

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
749704
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

3
  1. 21 CFR 211.25(a)Training--operations, GMPs, written procedures
  2. 21 CFR 211.22(a)Lack of quality control unit
  3. 21 CFR 211.142(a)Quarantine - written procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Airway Oxygen Inc.

1
DateClassificationOfficeProject area
May 21, 2014NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Airway Oxygen Inc.
  • FDA Inspection 879537 - 2014-05-21

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