FDA Inspection
Oxygen Service Co., Inc.Oxygen Service Co., Inc. – FDA Inspection, Jan 22, 2010
Record Details
This FDA Inspection record concerns Oxygen Service Co., Inc., with an inspection on January 22, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Oxygen Service Co., Inc.
- Inspection Date
- January 22, 2010
- Product Type
- Drugs
View Company Profile
ID · 8416c9c6-4da9-4867-9950-158c21796e3b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 640001
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 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 Oxygen Service Co., Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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