FDA Inspection
West Coast Laboratories, Inc.West Coast Laboratories, Inc. – FDA Inspection, Apr 11, 2018
Record Details
This FDA Inspection record concerns West Coast Laboratories, Inc., with an inspection on April 11, 2018, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · b54b0466-261a-422d-82a9-1401fe6abd80
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1047769
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
11- 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)(1)Specifications - component identity
- 21 CFR 111.303Written procedures - laboratory operations
- 21 CFR 111.365(g)Identifying, holding - contamination, mix-ups
- 21 CFR 111.140(b)(3)Records - material review, disposition documentation
- 21 CFR 111.325(b)(2)Laboratory methodology followed
- 21 CFR 111.75(c)(3)Specifications met identity,purity, strength, comp,; basis
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.205(b)(1)Master manufacturing record - specifications; quality
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Other FDA inspections of West Coast Laboratories, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2023 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 10, 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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