FDA Inspection
IEH Sani-pure Food Laboratories LlcIEH Sani-pure Food Laboratories Llc – FDA Inspection, Oct 20, 2010
Record Details
This FDA Inspection record concerns IEH Sani-pure Food Laboratories Llc, with an inspection on October 20, 2010, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Inspection Date
- October 20, 2010
- Product Type
- Food/cosmetics
View Company Profile
ID · aec75b39-ad3b-45cf-9b08-ec8a8f164d1e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 694535
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
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 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
- 21 CFR 111.315(e)Examination, testing; established criteria, quality control
Full citation text and observation details available on the Dashboard.
Other FDA inspections of IEH Sani-pure Food Laboratories Llc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for IEH Sani-pure Food Laboratories Llc
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.