FDA Inspection
West Coast Laboratories, Inc.West Coast Laboratories, Inc. – FDA Inspection, Oct 24, 2023
Record Details
This FDA Inspection record concerns West Coast Laboratories, Inc., with an inspection on October 24, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 918dbbe0-a021-4900-be92-2e97fe4234eb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1221426
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
20- 21 CFR 111.75(a)(2)Appropriate tests, examinations; certificate of analysis
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.75(c)Specifications met - verify; finished batch
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.205(b)(1)Master manufacturing record-specifications; packaged, label
- 21 CFR 111.123(a)(8)Quality control - finished batch, distribution
- 21 CFR 111.127(a)Quality control operations - labeling; visual examinations
- 21 CFR 111.155(c)(3)Quality control - components, approve, release
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Other FDA inspections of West Coast Laboratories, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 10, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 11, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 21, 2016 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| March 19, 2015 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 18, 2014 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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