FDA Inspection
Aero All-Gas CompanyAero All-Gas Company – FDA Inspection, Feb 24, 2010
Record Details
This FDA Inspection record concerns Aero All-Gas Company, with an inspection on February 24, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aero All-Gas Company
- Inspection Date
- February 24, 2010
- Product Type
- Drugs
View Company Profile
ID · da45e022-afbc-4f53-ad56-6c6108fecaef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 647613
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.100(a)Approval and review of procedures
- 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 |
|---|---|---|---|
| October 19, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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