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

Source: https://www.keypedia.com/records/483/bla-enterprises-llc-dba-green-mountain-pharmaceuticals/3dbfbd74-c020-498f-adaf-391e2dc1a4ce

> FDA 483 for BLA Enterprises, LLC dba Green Mountain Pharmaceuticals on December 08, 2016. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: BLA Enterprises, LLC dba Green Mountain Pharmaceuticals
- Inspection Date: 2016-12-08
- Product Type: drugs
- Office Name: Denver District Office
- Summary: 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.

## Related Documents

- [483 - 2021-12-13](https://www.keypedia.com/records/483/bla-enterprises-llc-dba-green-mountain-pharmaceuticals/8142e4e2-d61c-4fec-9b8c-63cf323338b4)

## Related Officers

- [Performance Improvement Coordinator](https://www.keypedia.com/people/tenzin-jangchup/733eb315-0eeb-40ce-af6d-03b406a9235d)
- [Zachary A. Bogorad](https://www.keypedia.com/people/zachary-a-bogorad/ae582dcd-f893-44a5-98bd-0b55f401577b)

Company: https://www.keypedia.com/companies/bla-enterprises-llc-dba-green-mountain-pharmaceuticals/85f4d1db-5118-4594-9356-787047f7bc33

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face