FDA Inspection
Dallas Oxygen CorporationDallas Oxygen Corporation – FDA Inspection, Feb 10, 2012
Record Details
This FDA Inspection record concerns Dallas Oxygen Corporation, with an inspection on February 10, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Dallas Oxygen Corporation
- Inspection Date
- February 10, 2012
- Product Type
- Drugs
View Company Profile
ID · 5d511524-a4b5-46e1-82e3-373009777a54
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 767320
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.44Adequate lighting not provided
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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