FDA Inspection
Complete H2O Minerals, Inc.Complete H2O Minerals, Inc. – FDA Inspection, Aug 18, 2017
Record Details
This FDA Inspection record concerns Complete H2O Minerals, Inc., with an inspection on August 18, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 4a496fa6-0e16-4cad-bc59-c82d52ca865b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1022115
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.303Written procedures - laboratory operations
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.155(d)(1)Components - identify lot received
- 21 CFR 111.160(d)(1)Packaging - identify
- 21 CFR 111.35(b)(1)Written procedures - equipment, utensils; make, keep
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.155(d)(2)Components - unique identifier
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Other FDA inspections of Complete H2O Minerals, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 15, 2021 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 11, 2018 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 5, 2014 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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