# FDA 483 - Pharma Nobis LLC - July 01, 2015

Source: https://www.globalkeysolutions.net/records/483/pharma-nobis-llc/972e0fc9-24aa-4684-8eb6-129b0a4e644e

> FDA 483 for Pharma Nobis LLC on July 01, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharma Nobis LLC
- Inspection Date: 2015-07-01
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Humco Holding Group, Inc. in Texarkana, TX, an OTC drug manufacturer, revealed significant deficiencies across multiple areas. The firm lacked adequate written procedures and process validation for drug products, failed to properly qualify its purified water system, and did not thoroughly investigate out-of-specification results or equipment discrepancies. These issues indicate a broad failure to adhere to current Good Manufacturing Practices.

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## Related Officers

- [Carlos Chavez](https://www.globalkeysolutions.net/people/carlos-chavez/63494a03-ee07-4a25-9298-75259b621c57)
- [Compliance Officer](https://www.globalkeysolutions.net/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)
- [Yumi Hiramine](https://www.globalkeysolutions.net/people/yumi-hiramine/26c5059f-8f61-42cf-ae79-65a7b942d2c7)

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