# FDA 483 - Signature Formulations, LLC - November 22, 2023

Source: https://www.globalkeysolutions.net/records/483/signature-formulations-llc/58d17961-66a8-44f5-ada4-af7f766c7891

> FDA 483 for Signature Formulations, LLC on November 22, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Signature Formulations, LLC
- Inspection Date: 2023-11-22
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Signature Formulations, LLC, a drug manufacturer in Phoenix, AZ, was cited for severe and repeat violations related to its quality control unit and manufacturing processes. The inspection revealed a lack of fundamental procedures for production controls, product testing, stability programs, and complaint handling. These systemic failures indicate a critical lack of control over drug product identity, strength, purity, and quality.

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## Related Officers

- [Bryan L. Mcguckin](https://www.globalkeysolutions.net/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

Company: https://www.globalkeysolutions.net/companies/signature-formulations-llc/d724b32c-8d17-4320-8e89-b38c3990c497

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