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# ‘Significant Violations’ at Sage Products
- URL: https://www.fdaweb.com/significant-violations-at-sage-products/
- Published: 2017-07-25T12:00:00.000Z
- Updated: 2026-09-14T22:36:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139208

A 6/2-9/1/16 FDA inspection at Sage Products, Cary, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 7/17 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm568120.htm?ref=fdaweb.com). Specific violations cited in the letter were: 

- failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods;
- failing to establish scientifically sound and appropriate sampling plans and test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality, and purity; and
- failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunction or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

The letter notes that Sage has engaged ChemRite to manufacture its Sage Perox-a-Mint and that those products are adulterated due to the violations listed above and due to reasons stated in a 6/29 Warning Letter to ChemRite indicating, among other things, that the company manufactured Sage oral solution drugs using the same equipment in which it manufactured toxic industrial-grade car washes and waxes.

“You are responsible for ensuring that all of your products are manufactured in accordance with CGMP, including oversight of the manufacturing operations conducted by your contractor, ChemRite, on your behalf,” the letter says…. “We strongly recommend engaging a consultant to assist your firm in meeting CGMP requirements.

Sage was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.