FDA Inspection
All Oxygen Refills, Inc.All Oxygen Refills, Inc. – FDA Inspection, Dec 18, 2009
Record Details
This FDA Inspection record concerns All Oxygen Refills, Inc., with an inspection on December 18, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- All Oxygen Refills, Inc.
- Inspection Date
- December 18, 2009
- Product Type
- Drugs
View Company Profile
ID · 79622451-64b9-46ed-bc86-efa638e112a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 635597
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
18- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(b)(5)In-process and laboratory control results
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.122(a)Sampling/testing of labeling/packaging materials
- 21 CFR 211.134(a)Correct labels during finishing operations
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
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