FDA Inspection
Sound Oxygen Service, Inc.Sound Oxygen Service, Inc. – FDA Inspection, Apr 30, 2010
Record Details
This FDA Inspection record concerns Sound Oxygen Service, Inc., with an inspection on April 30, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sound Oxygen Service, Inc.
- Inspection Date
- April 30, 2010
- Product Type
- Drugs
View Company Profile
ID · 597790df-1ef0-4c4c-92ab-5417c9c0ee86
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 662763
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Sound Oxygen Service, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 22, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 14, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sound Oxygen Service, Inc.
- FDA Inspection 909883 - 2015-01-22
- FDA Inspection 716299 - 2011-03-14
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