FDA Inspection
Sundial Herbs and Herbal Products EnterpriseSundial Herbs and Herbal Products Enterprise – FDA Inspection, Feb 17, 2017
Record Details
This FDA Inspection record concerns Sundial Herbs and Herbal Products Enterprise, with an inspection on February 17, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Inspection Date
- February 17, 2017
- Product Type
- Food/cosmetics
- Person
- Milan S. Mcgorty (Issuing Officer)
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ID · 3fcfe1e3-a0c0-4477-a2c3-e07b40b4e0b8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1003225
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 111.210(h)(3)Master manufacturing record - specific actions; quality
- 21 CFR 111.210(h)(1)Instructions; specifications; quality
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.503Written procedures - returned dietary supplement
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.155(d)(1)Components - identify lot received
- 21 CFR 111.255(b)Batch record - complete
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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 12, 2014 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| November 15, 2012 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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 867148 - 2014-02-12
- FDA Inspection 809138 - 2012-11-15
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