FDA Inspection
IEH Sani-pure Food Laboratories LlcIEH Sani-pure Food Laboratories Llc – FDA Inspection, Jun 15, 2012
Record Details
This FDA Inspection record concerns IEH Sani-pure Food Laboratories Llc, with an inspection on June 15, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 15, 2012
- Product Type
- Drugs
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ID · ebcafa2d-10d3-4745-a37c-0a28055669aa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 785342
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.194(b)Test method modification records not maintained
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
- 21 CFR 111.315(e)Examination, testing; established criteria, quality control
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Other FDA inspections of IEH Sani-pure Food Laboratories Llc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2010 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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