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# 4 Observations in Suretec Inspection
- URL: https://www.fdaweb.com/4-observations-in-suretec-inspection/
- Published: 2026-08-20T12:00:00.000Z
- Updated: 2026-09-14T12:05:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161657

A 3/2-3/5 FDA inspection at the Suretec Innovations drug manufacturing facility in Gilbert, AZ, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/13 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/suretec-innovations-llc-730122-08132026?ref=fdaweb.com) says the four specific violations were:

- failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failure to validate and establish the reliability of the company’s component supplier’s test analyses at appropriate intervals;
- failure to conduct appropriate laboratory testing, as necessary, for each batch of drug product required to be free of objectionable microorganisms;
- failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed; and
- failure of the firm’s quality control unit to exercise its responsibility to ensure manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

FDA recommends that Suretec engage a qualified consultant to evaluate its operations through a comprehensive six-system audit and assist it in meeting CGMP requirements.

The letter also says Suretec did not meet its drug listing requirement because it failed to list a sanitizing wipe product manufactured for a private label distributor.

The company was told to correct 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.