FDA Inspection
C K Solutions, Inc.C K Solutions, Inc. – FDA Inspection, Jun 20, 2019
Record Details
This FDA Inspection record concerns C K Solutions, Inc., with an inspection on June 20, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 64040bd3-0c49-40f4-9e9a-c082976c0e5d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1093679
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 111.75(a)(2)Appropriate tests, examinations; certificate of analysis
- 21 CFR 111.453Written procedures - holding
- 21 CFR 111.403Written procedures - labeling operations
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(b)(3)Specifications - contamination limits
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.75(c)Specifications met - verify; finished batch
- 21 CFR 111.255(b)Batch record - complete
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Other FDA inspections of C K Solutions, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2017 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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