FDA Inspection
Medcare Equipment CompanyMedcare Equipment Company – FDA Inspection, Sep 20, 2012
Record Details
This FDA Inspection record concerns Medcare Equipment Company, with an inspection on September 20, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Medcare Equipment Company
- Inspection Date
- September 20, 2012
- Product Type
- Drugs
View Company Profile
ID · 640b3180-a2bb-4a51-8a1e-5226b98641f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 801443
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Lack of quality control unit
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