FDA Inspection
Biocalth International, Inc.Biocalth International, Inc. – FDA Inspection, Aug 8, 2023
Record Details
This FDA Inspection record concerns Biocalth International, Inc., with an inspection on August 8, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · a2da3f69-1018-43b3-b0d5-ba8dd428efa3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1211725
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
12- 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 111.255(b)Batch record - complete
- 21 CFR 111.205(b)(2)Master manufacturing record - controls, procedures
- 21 CFR 111.160(c)(3)Labels - quality control; approve, release
- 21 CFR 111.105(i)QC - required operations master manufacturing/batch records
- 21 CFR 111.105(i)QC - required operations master manufacturing/batch records
- 21 CFR 111.160(c)(3)Labels - quality control; approve, release
- 21 CFR 111.205(b)(2)Master manufacturing record - controls, procedures
- 21 CFR 111.255(b)Batch record - complete
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Other FDA inspections of Biocalth International, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2017 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 3, 2015 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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