Ms. Maria Esparza
President and Owner
Signature Formulations, LLC
5446 W Roosevelt St., Ste 101
Phoenix , AZ 85043
United StatesFEI 3011368010Issued Jan 21, 2026Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3011368010.
Violations5
Issue DateJan 21, 2026
Product TypeDrugs
StatusOpen
Letter Details
Firm
Signature Formulations, LLC
Location
Ms. Maria Esparza
President and Owner
Signature Formulations, LLC
5446 W Roosevelt St., Ste 101
Phoenix , AZ 85043
United States
FEI Number
3011368010
Country
United States
Issue Date
January 21, 2026
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Signature Formulations, LLC, a manufacturer of over-the-counter drug products in Phoenix, Arizona, was cited for significant Current Good Manufacturing Practice (CGMP) violations on January 21, 2026, following an FDA inspection in July 2025. The company failed to maintain adequate facility separation and controls to prevent cross-contamination when manufacturing multiple drug products with potent active ingredients in a shared space using shared equipment, including a specific instance where equipment was used to manufacture a potent drug product immediately before manufacturing children's toothpaste. This manufacturing deficiency rendered the company's drug products adulterated and presented significant risk to patient safety, as the firm acknowledged only that contamination control systems were "under study" rather than implementing immediate corrective measures.
Signature Formulations, LLC FDA Warning Letter, January 21, 2026