FDA Inspection
InHome Oxygen and Medical Supplies, Inc.InHome Oxygen and Medical Supplies, Inc. – FDA Inspection, Apr 21, 2011
Record Details
This FDA Inspection record concerns InHome Oxygen and Medical Supplies, Inc., with an inspection on April 21, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 21, 2011
- Product Type
- Drugs
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ID · dd14cb57-0c9d-456b-a6d8-b5f05ee779ac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 723421
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
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