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# Repeat CGMP Violations at Signature Formulations
- URL: https://www.fdaweb.com/repeat-cgmp-violations-at-signature-formulations/
- Published: 2026-02-10T12:00:00.000Z
- Updated: 2026-09-14T13:33:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160636

A 7/21-7/29/2025 FDA inspection at the Signature Formulations drug manufacturing facility in Phoenix, AZ, found repeat significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 1/21 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/signature-formulations-llc-718093-01212026?ref=fdaweb.com) says the specific violations were:

- failure to perform operations within specifically defined areas of adequate size and to have separate or defined areas or other such control systems necessary to prevent contamination or mix-ups;
- failure 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;
- failure to have, for each batch of drug product, appropriate determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient before release, and failure to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms; and
- failure to establish an adequate quality control unit and to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit.

FDA reminds Signature Formulations that it is responsible for the quality of the drugs it produces as a contractor, regardless of agreements in place with product owners. It also notes that similar violations were cited in a 7/31/2018 Warning Letter, and the company had proposed specific remediations. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs are inadequate,” the agency says.

FDA recommends that Signature engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

The company was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.