FDA Inspection
S.K. Laboratories, Inc.S.K. Laboratories, Inc. – FDA Inspection, May 16, 2024
Record Details
This FDA Inspection record concerns S.K. Laboratories, Inc., with an inspection on May 16, 2024, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 9032c787-c175-4429-8c03-8a7ab89738e3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1238862
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
9- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(b)(3)Specifications - contamination limits
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.73Specifications met - component identity
- 21 CFR 111.65Quality control - quality, dietary supplement
- 21 CFR 111.260(f)Batch record - yield
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.260(h)Batch record - results; testing, examination; batch
Full citation text and observation details available on the Dashboard.
Other FDA inspections of S.K. Laboratories, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 22, 2025 | VAI | Los Angeles District Office | Food Composition, Standards, Labeling, and Economics |
| May 3, 2024 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 13, 2022 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 9, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| November 18, 2013 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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