FDA Inspection
Centura Home OxygenCentura Home Oxygen – FDA Inspection, Nov 19, 2010
Record Details
This FDA Inspection record concerns Centura Home Oxygen, with an inspection on November 19, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Centura Home Oxygen
- Inspection Date
- November 19, 2010
- Product Type
- Drugs
View Company Profile
ID · 9969f3f7-dd6c-4ed0-ae55-82531ac1067d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 700010
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.150Written distribution procedure
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.122(a)Written procedures not followed
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