FDA Inspection
LXR BiotechLXR Biotech – FDA Inspection, Jun 10, 2026
Record Details
This FDA Inspection record concerns LXR Biotech, with an inspection on June 10, 2026, issued by the Detroit District Office, covering foods & cosmetics.
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ID · 48900175-c5de-43a4-a264-44897c421ba6
Inspection Facts
- Inspection number
- 1321344
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
17- 21 CFR 111.105(i)Quality control - required operations
- 21 CFR 111.113(b)(2)Quality control - reject; specification not met
- 21 CFR 111.123(a)(8)Quality control - finished batch, distribution
- 21 CFR 111.12(b)Personnel - quality control operations; responsibilities
- 21 CFR 111.140(b)(2)Records - date and signature; review, approval, rejection
- 21 CFR 111.140(b)(3)Records - material review, disposition documentation
- 21 CFR 111.210Master manufacturing record - record requirements
- 21 CFR 111.260Batch record - required information
- 21 CFR 111.455(c)Hold - mix-up, contamination, deterioration
- 21 CFR 111.70(b)Specifications - components
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Other FDA inspections of LXR Biotech
6| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| February 8, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for LXR Biotech
- FDA Inspection 1263581 - 2025-03-12
- FDA Inspection 1229957 - 2024-02-16
- FDA Inspection 1200173 - 2023-02-15
- FDA Inspection 1195333 - 2023-01-20
- FDA Inspection 1083520 - 2019-02-08
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