# FDA 483 - Specialty Formulations & Manufacturing, LLC - February 20, 2019

Source: https://www.globalkeysolutions.net/records/483/specialty-formulations-manufacturing-llc/383559da-3015-499a-b20f-e34cb296504b

> FDA 483 for Specialty Formulations & Manufacturing, LLC on February 20, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Specialty Formulations & Manufacturing, LLC
- Inspection Date: 2019-02-20
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Specialty Formulations & Manufacturing, LLC in Phoenix, AZ, revealed significant deficiencies across its drug manufacturing operations. The firm failed to ensure drug product quality through inadequate testing, lack of stability programs, and poor component control. Key issues included the absence of a functional quality control unit, insufficient equipment cleaning and maintenance procedures, and deficient production controls and batch records.

## Related Documents

- [483 - 2025-09-12](https://www.globalkeysolutions.net/records/483/specialty-formulations-manufacturing-llc/08a129b8-853e-4ff1-80dd-8de3c5d077c0)

## Related Officers

- [Christopher M. Jenner](https://www.globalkeysolutions.net/people/christopher-m-jenner/d2fbd516-71aa-4263-8ffb-57b8149d6b64)

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