# FDA 483 - Specialty Formulations & Manufacturing, LLC - September 12, 2025

Source: https://www.globalkeysolutions.net/records/483/specialty-formulations-manufacturing-llc/08a129b8-853e-4ff1-80dd-8de3c5d077c0

> FDA 483 for Specialty Formulations & Manufacturing, LLC on September 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Specialty Formulations & Manufacturing, LLC
- Inspection Date: 2025-09-12
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Specialty Formulations & Manufacturing, LLC in Phoenix, AZ, a drug manufacturer, was cited with four observations during an FDA inspection. The firm lacks a functional quality control unit and adequate written procedures for equipment cleaning, raw material testing, and production process controls. These deficiencies indicate significant issues with the firm's adherence to cGMP regulations, potentially impacting drug product quality.

## Related Documents

- [483 - 2019-02-20](https://www.globalkeysolutions.net/records/483/specialty-formulations-manufacturing-llc/383559da-3015-499a-b20f-e34cb296504b)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kevin-t-nguyen/5ae9d562-7e4f-4305-895a-4b39c35acd16)

Company: https://www.globalkeysolutions.net/companies/specialty-formulations-manufacturing-llc/2a69e33b-e699-4174-af30-3876d2b10d5b

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