FDA Inspection
Med Resources IncMed Resources Inc – FDA Inspection, Jun 1, 2010
Record Details
This FDA Inspection record concerns Med Resources Inc, with an inspection on June 1, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Med Resources Inc
- Inspection Date
- June 1, 2010
- Product Type
- Drugs
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ID · 10ab3f23-f30e-44eb-940c-e70f44a66bb6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 664407
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.150Written distribution procedure
- 21 CFR 211.80(a)Procedures To Be in Writing
Showing 10 of 12 citations.
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Other FDA inspections of Med Resources Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Med Resources Inc
- FDA Inspection 741514 - 2011-08-17
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