BLA Enterprises, LLC dba Green Mountain PharmaceuticalsDecember 8, 2016

FDA 483 - BLA Enterprises, LLC dba Green Mountain Pharmaceuticals - December 08, 2016

View on Dashboard

Discuss this record with AI

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 BLA Enterprises, LLC dba Green Mountain Pharmaceuticals

Record Details

BLA Enterprises LLC dba Green Mountain Pharmacy, an API and dietary supplement manufacturer in Lakewood, CO, received a Form 483 with 12 observations. The inspection revealed significant deficiencies across quality systems, including inadequate investigations, lack of supplier qualification, incomplete cleaning validation, and insufficient equipment qualification. These issues indicate a systemic failure to ensure product quality, purity, and safety.

Company: BLA Enterprises, LLC dba Green Mountain Pharmaceuticals
Inspection Date: December 8, 2016
Product Type: Drugs
Office: Denver District Office
People: Tenzin Jangchup (Performance Improvement Coordinator)
Zachary A. Bogorad

Open in Dashboard

ID · 3dbfbd74-c020-498f-adaf-391e2dc1a4ce