FDA Inspection
LXR BiotechLXR Biotech – FDA Inspection, May 23, 2018
Record Details
This FDA Inspection record concerns LXR Biotech, with an inspection on May 23, 2018, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- John N. Woodall (Issuing Officer)
- Lauren E. Sexton (Issuing Officer)
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ID · 847b043b-fd78-436c-a4cc-5556c9f1f602
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1053753
- 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)(ii)(B)Component - certificate of analysis
- 21 CFR 111.80(a)Components packaging, labels received
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.73Specifications met - identity, purity, strength, composition
- 21 CFR 111.65Quality control - quality, dietary supplement
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
- 21 CFR 111.155(c)Components - quarantine
- 21 CFR 111.83(b)(3)Reserve sample - retained
- 21 CFR 111.260(f)Batch record - yield
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Other FDA inspections of LXR Biotech
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2026 | Not classified | Detroit District Office | Foodborne Biological Hazards |
| March 12, 2025 | Not classified | Detroit District Office | Foodborne Biological Hazards |
| February 16, 2024 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 15, 2023 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| January 20, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for LXR Biotech
- FDA Inspection 1321344 - 2026-06-10
- FDA Inspection 1263581 - 2025-03-12
- FDA Inspection 1229957 - 2024-02-16
- FDA Inspection 1200173 - 2023-02-15
- FDA Inspection 1195333 - 2023-01-20
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