FDA Inspection
Arkansas Home Medical, Inc.Arkansas Home Medical, Inc. – FDA Inspection, Apr 4, 2013
Record Details
This FDA Inspection record concerns Arkansas Home Medical, Inc., with an inspection on April 4, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Arkansas Home Medical, Inc.
- Inspection Date
- April 4, 2013
- Product Type
- Drugs
View Company Profile
ID · 5028cf77-e6f9-4a41-80e0-b917da8e97c6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 825911
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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