FDA Inspection
Sundial Herbs and Herbal Products EnterpriseSundial Herbs and Herbal Products Enterprise – FDA Inspection, Nov 15, 2012
Record Details
This FDA Inspection record concerns Sundial Herbs and Herbal Products Enterprise, with an inspection on November 15, 2012, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Inspection Date
- November 15, 2012
- Product Type
- Food/cosmetics
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ID · d0e6ddd6-637b-42c2-b746-4e8fff313595
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 809138
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
10- 21 CFR 111.75(i)Corrective action plan
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.65Quality control - quality, dietary supplement
- 21 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
- 21 CFR 111.35(b)(4)Records - equipment; calibrations, inspections, checks
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.27(a)Equipment - design - suitable
- 21 CFR 111.27(a)(3)(v)Equipment - protect from contamination
- 21 CFR 111.20(h)Physical plant - screening against pests
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Other FDA inspections of Sundial Herbs and Herbal Products Enterprise
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2025 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 23, 2024 | Not classified | New York District Office | |
| April 19, 2021 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| February 17, 2017 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 12, 2014 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Sundial Herbs and Herbal Products Enterprise
- FDA Inspection 1274653 - 2025-06-25
- FDA Inspection 1229503 - 2024-04-23
- FDA Inspection 1141016 - 2021-04-19
- FDA Inspection 1003225 - 2017-02-17
- FDA Inspection 867148 - 2014-02-12
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