FDA Inspection
Ohio Valley Herbal Products, Inc.Ohio Valley Herbal Products, Inc. – FDA Inspection, Sep 8, 2011
Record Details
This FDA Inspection record concerns Ohio Valley Herbal Products, Inc., with an inspection on September 8, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 8, 2011
- Product Type
- Drugs
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ID · b929ade3-18f8-426f-9be8-fb7047ac671c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 746962
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.80(d)Disposition recorded by lot identification
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 111.415(f)(1)Batch-lot,control number packaged, labeled dietary supplemen
- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.70(g)Specifications - finished packaging, labeling
- 21 CFR 111.70(f)Specifications - product received for packaging, labeling
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