FDA Inspection
Dubois Medical Supply Company, Inc dba Ellwood Resp CareDubois Medical Supply Company, Inc dba Ellwood Resp Care – FDA Inspection, Nov 20, 2008
Record Details
This FDA Inspection record concerns Dubois Medical Supply Company, Inc dba Ellwood Resp Care, with an inspection on November 20, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 20, 2008
- Product Type
- Drugs
View Company Profile
ID · e901c2f4-6203-4554-9d20-9ca4c33f3f56
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 547660
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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