Microbiome Health Research Institute (dba OpenBiome) – FDA Inspection, Aug 14, 2024

Record Details

This FDA Inspection record concerns Microbiome Health Research Institute (dba OpenBiome), with an inspection on August 14, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company: Microbiome Health Research Institute (dba OpenBiome)
Inspection Date: August 14, 2024
Product Type: Biologics
Office: Center for Biologics Evaluation and Research
Person: Jose A. Torres (Company Rep)

View Company Profile

ID · e5fbd800-248a-4369-bc81-1c583b7495c7

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1246341
FDA center: Biologics
Project area: Bioresearch Monitoring

FDA Citations

21 CFR 312.7(b)Commercial distribution of an investigational drug

Full citation text and observation details available on the Dashboard.

Discuss this record with AI

KeyPedia

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Microbiome Health Research Institute (dba OpenBiome)

FDA Inspection

Microbiome Health Research Institute (dba OpenBiome)August 14, 2024