FDA warning letter to West Jordan, Utah maker SnugZ cites retesting failed microbial results until they passed
Key facts
- Type / category
- News / Warning letter
- Agency
- FDA
- Source date
- Sectors
- Cosmetics, Supplements
- Reference
- MARCS-CMS 735284
On October 20, 2026, FDA posted a September 28, 2026 warning letter to SnugZ USA, Inc. of West Jordan, Utah, which makes over-the-counter (OTC) drug products that its customers mainly distribute as promotional items. FDA inspected the facility at 9258 South Prosperity Road from April 27 to May 1, 2026 and cited violations of the drug CGMP regulations in 21 CFR parts 210 and 211. According to the letter, the firm routinely failed to investigate out-of-specification (OOS) chemical and microbiological results, including system monitoring samples, and retested failing samples or prepared new ones until analysts got passing results, which it then used to release product.
FDA notes that the firm's Microbial Testing SOP allowed retesting after an initial failure and, if the retest failed, switching to a second microbiological testing instrument. The firm routinely invalidated failing release results from the first system and released product on passing results from the second, without data supporting this tiered approach or showing one method was superior. The letter also cites inadequate identity testing of incoming components, reliance on suppliers' certificates of analysis without confirming their reliability, and quality unit failures including cleaning validation, annual product reviews and record review. FDA said inadequate investigations were a repeat finding after an April 1, 2022 regulatory meeting. It asked for a retrospective, independent review of all invalidated OOS results for products on the market and recommended a qualified CGMP consultant.
What it means for labs
Passing retest results alone cannot invalidate a failing microbial result, and switching to a different test method or instrument needs data showing the methods are equivalent. Labs and manufacturers in Utah and elsewhere may want to check that their OOS procedures require an investigation of every initial failure before any retest.
Who it affects
Manufacturers and in-house labs that release product on microbial test results, including Utah OTC, cosmetic and supplement makers
Sources
This summary is for general information and may not reflect later changes. Always check the official source linked above. It isn't legal or regulatory advice, and Micro-Core Consulting isn't affiliated with the agencies or standards bodies named.