FDA Inspection
Med-Ox Home MedicalMed-Ox Home Medical – FDA Inspection, Feb 7, 2013
Record Details
This FDA Inspection record concerns Med-Ox Home Medical, with an inspection on February 7, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Med-Ox Home Medical
- Inspection Date
- February 7, 2013
- Product Type
- Drugs
View Company Profile
ID · c71af26a-44da-43c3-a113-e76b4931018d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 817866
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.180(e)(1)Review of representative number of batches
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