483
Signature Formulations, LLCFDA 483 - Signature Formulations, LLC - November 22, 2023
Record Details
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.
- Office
- Denver District Office
- Person
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ID · 58d17961-66a8-44f5-ada4-af7f766c7891