FDA Inspection
S Bailey Enterprises, LLCS Bailey Enterprises, LLC – FDA Inspection, Jul 19, 2019
Record Details
This FDA Inspection record concerns S Bailey Enterprises, LLC, with an inspection on July 19, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Debra A. Taylor (Issuing Officer)
- Sandy L. Atkins (Issuing Officer)
- Shannon Atlas (Issuing Officer)
- Shelton L. Stribling (Issuing Officer)
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ID · bc0093f0-605a-4a83-86d3-a201a0fb1483
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1097303
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 111.20(d)(2)Air blowing equipment
- 21 CFR 111.12(c)Personnel - education, training, experience
- 21 CFR 111.70(a)Specifications - manufacturing process
- 21 CFR 111.155(d)(1)Components - identify lot received
- 21 CFR 111.65Quality control - quality, dietary supplement
- 21 CFR 111.27(d)Equipment - maintain, clean, sanitize
- 21 CFR 111.15(b)(1)Physical plant - clean and sanitary
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
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Other FDA inspections of S Bailey Enterprises, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2025 | VAI | New Orleans District Office | Foodborne Biological Hazards |
| December 13, 2021 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 17, 2016 | OAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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