FDA Inspection
Vantage Home Mecical Equipment LLCVantage Home Mecical Equipment LLC – FDA Inspection, Mar 3, 2017
Record Details
This FDA Inspection record concerns Vantage Home Mecical Equipment LLC, with an inspection on March 3, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · cf9ba9aa-6fda-40bb-9256-2c20c09e2494
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005612
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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