FDA Inspection
Xymogen Manufacturing, LLCXymogen Manufacturing, LLC – FDA Inspection, May 24, 2013
Record Details
This FDA Inspection record concerns Xymogen Manufacturing, LLC, with an inspection on May 24, 2013, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Xymogen Manufacturing, LLC
- Inspection Date
- May 24, 2013
- Product Type
- Food/cosmetics
View Company Profile
ID · 5bac5809-1107-49a5-aa5c-8ec36e00bd09
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 833513
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
9- 21 CFR 111.570(b)(2)(ii)(F)Record - product complaint; findings
- 21 CFR 111.75(h)Tests, examinations - scientifically valid
- 21 CFR 111.27(d)Equipment - maintain, clean, sanitize
- 21 CFR 111.365(a)Conditions, controls -protect; microorganisms, contamination
- 21 CFR 111.27(a)Equipment - design - suitable
- 21 CFR 111.75(c)Specifications met - verify; finished batch
- 21 CFR 111.13(a)Supervisor - qualified
- 21 CFR 111.455(c)Hold - mix-up, contamination, deterioration
- 21 CFR 111.10(b)Personnel - hygienic practices
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Other FDA inspections of Xymogen Manufacturing, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 13, 2024 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 8, 2022 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 16, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 10, 2014 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 6, 2012 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
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