Regulations

FDA Issues Warning Letter to Signature Formulations

This follows a recall and summarizes violations of CGMP regulations.

After a recent recall on kids toothpaste and mouthwash, as reported in Happi, the United States Food and Drug Administration (FDA) issues a warning letter to Signature Formulations of Phoenix, AZ for violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The FDA inspected the drug manufacturing facility of Signature Formulations from July 21-29, 2025. It said: “This warning letter See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 ...

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