FDA Inspection
Oxygen Service Co., Inc.Oxygen Service Co., Inc. – FDA Inspection, Oct 24, 2013
Record Details
This FDA Inspection record concerns Oxygen Service Co., Inc., with an inspection on October 24, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Oxygen Service Co., Inc.
- Inspection Date
- October 24, 2013
- Product Type
- Drugs
View Company Profile
ID · 255b6b05-bfe8-484c-82e8-351cd0965213
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 852966
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 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 |
|---|---|---|---|
| January 22, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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