FDA Inspection
Calmar dba A&R Medical SupplyCalmar dba A&R Medical Supply – FDA Inspection, Sep 12, 2012
Record Details
This FDA Inspection record concerns Calmar dba A&R Medical Supply, with an inspection on September 12, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 12, 2012
- Product Type
- Drugs
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ID · cce03c55-d883-46ff-a0c3-2b376a861c32
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 799730
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.80(a)Written Procedures Not Followed
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Other FDA inspections of Calmar dba A&R Medical Supply
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 4, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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