FDA Inspection
Aero Compressed Gases, Inc.Aero Compressed Gases, Inc. – FDA Inspection, Jul 27, 2012
Record Details
This FDA Inspection record concerns Aero Compressed Gases, Inc., with an inspection on July 27, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aero Compressed Gases, Inc.
- Inspection Date
- July 27, 2012
- Product Type
- Drugs
View Company Profile
ID · f424ba0a-a4a2-49e5-91a0-297b2c09b711
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 792524
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Aero Compressed Gases, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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