FDA Inspection
Oxygen Plus, Inc. dba Summit RespiratoryOxygen Plus, Inc. dba Summit Respiratory – FDA Inspection, Oct 14, 2010
Record Details
This FDA Inspection record concerns Oxygen Plus, Inc. dba Summit Respiratory, with an inspection on October 14, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 14, 2010
- Product Type
- Drugs
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ID · 5f2ad61f-54f9-439e-8843-4ece35e760f9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 685899
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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