FDA Inspection
Olympic Ambulance Service, Inc. dba Olympic Oxygen ServiceOlympic Ambulance Service, Inc. dba Olympic Oxygen Service – FDA Inspection, Feb 18, 2011
Record Details
This FDA Inspection record concerns Olympic Ambulance Service, Inc. dba Olympic Oxygen Service, with an inspection on February 18, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 18, 2011
- Product Type
- Drugs
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ID · d35894a0-76fb-4b8c-aa9c-2b60dfbaa9ba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 709415
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.122(a)Written procedures not followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Olympic Ambulance Service, Inc. dba Olympic Oxygen Service
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 16, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Olympic Ambulance Service, Inc. dba Olympic Oxygen Service
- FDA Inspection 816469 - 2012-12-13
- FDA Inspection 753540 - 2011-11-16
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