FDA Inspection
Lake Erie Medical & Surgical SupplyLake Erie Medical & Surgical Supply – FDA Inspection, Oct 20, 2016
Record Details
This FDA Inspection record concerns Lake Erie Medical & Surgical Supply, with an inspection on October 20, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 532c45b8-fda2-4730-8362-96a127c24d5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 989446
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.188(b)(6)Documentation of Packaging and Labeling Area Inspections
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Lake Erie Medical & Surgical Supply
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 12, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 26, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lake Erie Medical & Surgical Supply
- FDA Inspection 707128 - 2011-01-12
- FDA Inspection 624126 - 2009-10-26
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