# FDA 483 - Pharma Nobis LLC - March 13, 2020

Source: https://www.globalkeysolutions.net/records/483/pharma-nobis-llc/811120a6-d13f-42af-9a81-d010417518de

> FDA 483 for Pharma Nobis LLC on March 13, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharma Nobis LLC
- Inspection Date: 2020-03-13
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Humco Holding Group, Inc., a drug manufacturer/repackager in Texarkana, TX, was cited for significant deficiencies across its quality, laboratory, facilities, materials, and production systems. The inspection revealed widespread issues including inadequate investigations into out-of-specification results, lack of proper stability testing programs and documentation, deficient laboratory records, and poorly defined cleaning procedures. Additionally, the firm failed to adequately qualify suppliers and ensure proper testing of incoming active pharmaceutical ingredients.

## Related Documents

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- [483 - 2025-07-25](https://www.globalkeysolutions.net/records/483/pharma-nobis-llc/416a69dd-78dd-4267-8432-cf07bcaf759d)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/shanna-n-purdy/7a677cf5-484f-4e9a-91b1-27398411ff32)
- [Michelle A. Krayer](https://www.globalkeysolutions.net/people/michelle-a-krayer/c68b88a6-d3d3-4407-867b-81b92b7ce977)
- [Margaret M. Annes](https://www.globalkeysolutions.net/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.globalkeysolutions.net/companies/pharma-nobis-llc/65e636d3-cd04-456d-b82a-a681bb7bdb9e

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9