FDA Inspection
Vita-Herb Nutriceuticals IncVita-Herb Nutriceuticals Inc – FDA Inspection, Dec 12, 2016
Record Details
This FDA Inspection record concerns Vita-Herb Nutriceuticals Inc, with an inspection on December 12, 2016, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · d4305b80-7e98-4b86-8f21-8cd4583056ff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 994821
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.180(e)(1)Review of representative number of batches
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Other FDA inspections of Vita-Herb Nutriceuticals Inc
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 4, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 29, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 26, 2012 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 30, 2011 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 22, 2011 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Vita-Herb Nutriceuticals Inc
- FDA Inspection 1089410 - 2019-04-04
- FDA Inspection 922272 - 2015-04-29
- FDA Inspection 788676 - 2012-06-26
- FDA Inspection 742103 - 2011-08-30
- FDA Inspection 730837 - 2011-06-22
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