FDA inspection

BioLyte Laboratories, LLC: FDA inspection ending Sep 12, 2025

FDA inspection 1287796 · Official Action Indicated (OAI) · Grand Rapids, MI

Key facts

Inspection ID 1287796
Firm BioLyte Laboratories, LLC
FEI number 3013171766
Address 310 Northern Dr Nw
City Grand Rapids
State MI
ZIP 49534
Country United States
Fiscal year 2025
Inspection end date Sep 12, 2025
Classification Official Action Indicated (OAI)
Project area Drug Quality Assurance
Product type Drugs

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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