FDA Inspection
BioLyte Laboratories, LLCBioLyte Laboratories, LLC – FDA Inspection, Apr 27, 2023
Record Details
This FDA Inspection record concerns BioLyte Laboratories, LLC, with an inspection on April 27, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 68889779-b5bc-42f1-b9da-edc8160e765b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1205037
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of BioLyte Laboratories, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2025 | Not classified | Detroit District Office | |
| April 6, 2023 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| December 18, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for BioLyte Laboratories, LLC
- FDA Inspection 1287796 - 2025-09-12
- FDA Inspection 1203096 - 2023-04-06
- FDA Inspection 1113105 - 2019-12-18
- FDA Inspection 1035012 - 2017-12-15
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