# FDA 483 - Huvepharma, Inc. - April 23, 2019

Source: https://www.globalkeysolutions.net/records/483/huvepharma-inc/859eb647-fc77-465f-ba36-9c4c025f4384

> FDA 483 for Huvepharma, Inc. on April 23, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Huvepharma, Inc.
- Inspection Date: 2019-04-23
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Huvepharma, Inc. in Longmont, CO, was inspected and cited for significant deficiencies in its quality control unit's responsibilities and procedures, particularly regarding document control and contractor oversight. The inspection also revealed a failure to thoroughly investigate product discrepancies and inadequate raw material sampling procedures. These issues indicate a systemic lack of robust quality management and could impact product quality and control.

## Related Officers

- [Food and Nutration Service ](https://www.globalkeysolutions.net/people/farhana-khan/2388f1b3-b96c-4ae9-a520-d469ef762ce9)

Company: https://www.globalkeysolutions.net/companies/huvepharma-inc/f7e97afe-1efa-4ded-a347-4bbed4c74058

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