FDA Inspection
Columbia Medical Equipment IncColumbia Medical Equipment Inc – FDA Inspection, Jan 28, 2011
Record Details
This FDA Inspection record concerns Columbia Medical Equipment Inc, with an inspection on January 28, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 28, 2011
- Product Type
- Drugs
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ID · 12c9c7d3-2ac1-4866-bc17-1b41fc476816
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 708257
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.198(b)Maintenance of Complaint File
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.101(a)Batches Formulated to less than 100%
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