# FDA 483 - Signature Formulations, LLC - September 30, 2021

Source: https://www.globalkeysolutions.net/records/483/signature-formulations-llc/9331a680-2532-4ef6-aaf2-341e1d19ba14

> FDA 483 for Signature Formulations, LLC on September 30, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Signature Formulations, LLC
- Inspection Date: 2021-09-30
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Signature Formulations, LLC in Phoenix, AZ, was inspected and found to have severe deficiencies across its laboratory, quality, and production systems. The firm failed to ensure drug product quality through inadequate testing, lack of specifications, and a non-existent quality control unit. Repeated observations highlight a systemic failure to adhere to basic manufacturing and quality control principles.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/alan-m-barker/cf7b4907-0505-418e-860c-815acd534afe)
- [Christopher M. Jenner](https://www.globalkeysolutions.net/people/christopher-m-jenner/d2fbd516-71aa-4263-8ffb-57b8149d6b64)

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