Company
United StatesBioLyte Laboratories, LLC, Grand Rapids, MI – FDA Inspections
Inspection records and compliance data for BioLyte Laboratories, LLC in Grand Rapids, Michigan. 5 FDA inspections on record (2 OAI), 3 Form 483s, 1 warning letter, last inspected September 12, 2025.
Company Profile
This profile covers BioLyte Laboratories, LLC based in Grand Rapids, Michigan, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 2
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 1
First inspected December 15, 2017. Last inspected September 12, 2025.
Most cited issue areas
- Changes to Procedures Not Reviewed, Approved2 inspections
- Procedures not in writing, fully followed2 inspections
- Testing and release for distribution2 inspections
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 12, 2025 | Not classified | Human Drugs | 1287796 |
| April 27, 2023 | OAI | Human Drugs · Drug Quality Assurance | 1205037 |
| April 6, 2023 | NAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 1203096 |
| December 18, 2019 | OAI | Human Drugs · Drug Quality Assurance | 1113105 |
| December 15, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1035012 |
FDA documents
Warning Letters (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
BioLyte Laboratories, LLC
FEI Number
3013171766
Address
310 Northern Dr Nw, Grand Rapids, Michigan 49534, United States
Country
United States
ID: 72aab89c-4774-4dcb-9daa-42d74b544922