Airtec Gases, LLC. – FDA Inspection, Jan 30, 2018

Record Details

This FDA Inspection record concerns Airtec Gases, LLC., with an inspection on January 30, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Airtec Gases, LLC.
Inspection Date: January 30, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Zachary L. Stamm (FDA Associated Person)

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ID · c471697e-02c2-4726-a248-24b4f79365d3

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1039326
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.68(a)Calibration/Inspection/Checking not done
21 CFR 211.188(b)Batch production and Batch Control Record Requirements
21 CFR 211.22(d)Procedures not in writing, fully followed

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FDA Inspection

Airtec Gases, LLC.January 30, 2018