FDA Inspection
VitaSea Products Int'l , Inc. dba Wachters' Organic Sea ProductsVitaSea Products Int'l , Inc. dba Wachters' Organic Sea Products – FDA Inspection, Jul 19, 2018
Record Details
This FDA Inspection record concerns VitaSea Products Int'l , Inc. dba Wachters' Organic Sea Products, with an inspection on July 19, 2018, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Inspection Date
- July 19, 2018
- Product Type
- Food/cosmetics
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ID · 3c253d5d-7a24-45e2-9be1-3fc8acfdbc2c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1059451
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 111.27(d)(6)Cleaning compounds - adequate, safe
- 21 CFR 111.530Returned dietary supplement - investigation
- 21 CFR 111.315(b)(1)Sampling plans; components
- 21 CFR 111.70(a)Specifications - manufacturing process
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.460(b)Hold - in-process material; temperature, humidity, light
- 21 CFR 111.65Quality control - quality, dietary supplement
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.365Manufacturing operations - prevent contamination
- 21 CFR 111.255(c)Batch record - follow master
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Other FDA inspections of VitaSea Products Int'l , Inc. dba Wachters' Organic Sea Products
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 19, 2017 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 17, 2015 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| November 29, 2012 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for VitaSea Products Int'l , Inc. dba Wachters' Organic Sea Products
- FDA Inspection 1016237 - 2017-06-19
- FDA Inspection 924064 - 2015-04-17
- FDA Inspection 818859 - 2012-11-29
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