FDA Inspection
Aero All-Gas CompanyAero All-Gas Company – FDA Inspection, Oct 19, 2017
Record Details
This FDA Inspection record concerns Aero All-Gas Company, with an inspection on October 19, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Dien N. Nguyen (Issuing Officer)
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ID · 699b3044-2c34-4506-9e87-6843b73db8ef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029169
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.198(a)Reporting of adverse drug experience to FDA
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Other FDA inspections of Aero All-Gas Company
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 24, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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