# FDA 483 - Signature Formulations, LLC - July 29, 2025

Source: https://www.globalkeysolutions.net/records/483/signature-formulations-llc/74e4bd45-82da-43dc-9298-40252f1d67af

> FDA 483 for Signature Formulations, LLC on July 29, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Signature Formulations, LLC
- Inspection Date: 2025-07-29
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Signature Formulations, LLC in Phoenix, AZ, a drug manufacturer, revealed significant and repeat deficiencies across multiple systems. The firm was cited for inadequate equipment cleaning, poor contamination control for hazardous APIs, lack of proper product testing and stability studies, and unvalidated manufacturing processes and water systems. These findings indicate a serious lack of adherence to Good Manufacturing Practices, posing risks to drug product quality and safety.

## Related Documents

- [483 - 2017-11-09](https://www.globalkeysolutions.net/records/483/signature-formulations-llc/3cdf3a02-2219-47be-a4fd-cf911f70a04a)
- [483 - 2021-09-30](https://www.globalkeysolutions.net/records/483/signature-formulations-llc/9331a680-2532-4ef6-aaf2-341e1d19ba14)
- [483 - 2023-11-22](https://www.globalkeysolutions.net/records/483/signature-formulations-llc/58d17961-66a8-44f5-ada4-af7f766c7891)
- [WARNING_LETTER - 2025-07-29](https://www.globalkeysolutions.net/records/warning_letter/signature-formulations-llc/db82b61b-80a1-479d-89de-921274f02374)

## Related Officers

- [Michael E. Weigman](https://www.globalkeysolutions.net/people/michael-e-weigman/fe9f88f1-7bc4-425e-8757-40c1eef7c939)
- [Michael Z. Weigman](https://www.globalkeysolutions.net/people/michael-z-weigman/fcf79bb1-87cc-476c-a1af-758ef0126ee9)
- [Stephon D. Tillis](https://www.globalkeysolutions.net/people/stephon-d-tillis/32a4b5de-0dcc-4233-b7c8-b25cf691a138)
- [Senior CSO, Investigator](https://www.globalkeysolutions.net/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)

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