FDA Inspection
American Pure WheyAmerican Pure Whey – FDA Inspection, Nov 17, 2016
Record Details
This FDA Inspection record concerns American Pure Whey, with an inspection on November 17, 2016, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Person
- Mancia R. Walker (Issuing Officer)
View Company Profile
ID · a221904e-64f2-4afa-9937-15814738ccad
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 992711
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 111.353Manufacturing operations - written procedures
- 21 CFR 111.535(b)(2)Records - ret"nd dietary supplement: material review, dispos
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.15(d)(2)Pest control measures
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.60(a)Production, in- process control system - design, quality
- 21 CFR 111.535(b)(2)Records - ret'nd dietary supplement: material review, dispos
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Other FDA inspections of American Pure Whey
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2019 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 18, 2015 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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