# FDA 483 - BLA Enterprises, LLC dba Green Mountain Pharmaceuticals - December 13, 2021

Source: https://www.globalkeysolutions.net/records/483/bla-enterprises-llc-dba-green-mountain-pharmaceuticals/8142e4e2-d61c-4fec-9b8c-63cf323338b4

> FDA 483 for BLA Enterprises, LLC dba Green Mountain Pharmaceuticals on December 13, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BLA Enterprises, LLC dba Green Mountain Pharmaceuticals
- Inspection Date: 2021-12-13
- Product Type: drugs
- Office Name: Denver District Office
- Summary: BLA Enterprises, LLC dba Green Mountain Pharmaceuticals, a drug manufacturer in Lakewood, CO, was cited for significant deficiencies across its quality, production, and labeling systems. The inspection revealed inadequate investigations into discrepancies and out-of-specification results, a failure to conduct required internal audits, and a lack of proper process validation and record-keeping for master batch records. Additionally, the firm did not maintain strict control over labeling reconciliation.

## Related Documents

- [483 - 2016-12-08](https://www.globalkeysolutions.net/records/483/bla-enterprises-llc-dba-green-mountain-pharmaceuticals/3dbfbd74-c020-498f-adaf-391e2dc1a4ce)

## Related Officers

- [Consumer Safety Officer (Drug Specialist)](https://www.globalkeysolutions.net/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)

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

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