FDA Inspection
Chaga Mountain, Inc.Chaga Mountain, Inc. – FDA Inspection, Aug 7, 2019
Record Details
This FDA Inspection record concerns Chaga Mountain, Inc., with an inspection on August 7, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · c686bf23-badf-4710-b12b-9f9f774e1b17
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1099160
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 111.105(a)Quality control - processes, specifications, written procedures
- 21 CFR 111.155(d)(1)Components - identify lot produced
- 21 CFR 111.210(f)Master manufacturing record theoretical and expected yield
- 21 CFR 111.260(l)(3)Batch record - approved, released, rejected; batch
- 21 CFR 111.35(b)(3)Documentation - instruments, controls; calibrations
- 21 CFR 111.403Written procedures - labeling operations
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.70(b)(3)Specifications - contamination limits
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
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Other FDA inspections of Chaga Mountain, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2016 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 1, 2015 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 1, 2014 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 16, 2013 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Chaga Mountain, Inc.
- FDA Inspection 982561 - 2016-08-23
- FDA Inspection 934411 - 2015-07-01
- FDA Inspection 899469 - 2014-10-01
- FDA Inspection 849334 - 2013-09-16
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