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 (21 CFR parts 210 and 211).

“Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).”

“We reviewed your Aug. 29, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

“During our inspection, our investigators observed specific violations including, but not limited to, the following.

“1. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)).

“On Dec. 2, 2025, FDA held a teleconference with you recommending you consider removing any batches of ORL Kid’s Natural Toothpaste and ORL Kid’s mouthwash currently in distribution from the US market.

“On Dec. 8, 2025, you issued a voluntarily recall of ORL kids bubblegum toothpaste lot number 250520P4-05/27 and ORL kids bubblegum mouthwash lot number 250505P9-05/27 due to potential contamination with exogenous hormones.

“2. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

“3. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).

“4. Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)).

Read the full letter here.