On June 6, 2025, the U.S. Food and Drug Administration (FDA) sent a stern warning letter to Horizon Tool Inc., a Greensboro, North Carolina-based company, following an inspection of their manufacturing facility from January 14 to 16, 2025. The FDA flagged serious violations of Current Good Manufacturing Practice (CGMP) regulations for their product, AllShield E2 Sanitizing Hand Soap, raising concerns about product safety and quality.
### Key Violations Uncovered
1. **No Microbiological Testing Conducted**
The FDA found that Horizon Tool Inc. failed to perform required microbiological testing on a batch of AllShield E2 Sanitizing Hand Soap (lot 25009). According to the inspection, no samples were collected for testing, and the company’s quality assurance team couldn’t explain why. This oversight means there’s no evidence to confirm the product is free from harmful microorganisms, a critical requirement under federal regulations (21 CFR 211.165(b)). Without this testing, consumers could be at risk from contaminated products.
2. **Missing Stability Testing Program**
The company also neglected to conduct stability testing for the same hand soap product. Stability testing ensures a product remains safe and effective throughout its shelf life, but Horizon Tool Inc. provided no data to support this. Their response to the FDA admitted the issue but fell short, lacking details on corrective actions or a risk assessment for products already on the market. This gap violates CGMP standards and undermines trust in the product’s quality.
### Why This Matters
The FDA classified AllShield E2 Sanitizing Hand Soap as "adulterated" under federal law (21 U.S.C. 351(a)(2)(B)) because it was manufactured in a facility not adhering to CGMP standards. This designation signals serious quality control issues that could compromise consumer safety. The FDA stressed that the violations listed aren’t exhaustive, meaning other problems may exist. Horizon Tool Inc. is now responsible for investigating and resolving all issues to prevent future violations.
### What’s Next for Horizon Tool Inc.?
The FDA has given Horizon Tool Inc. 15 working days to respond with a detailed plan to address these violations. This includes a thorough assessment of their manufacturing processes and a corrective action and preventive action (CAPA) plan to fix their stability testing program. Failure to comply could lead to serious consequences, such as product seizures, legal injunctions, or restrictions on federal contracts and export certificates. The FDA may also block approval of any new drug applications from the company until compliance is confirmed, potentially through a follow-up inspection.
### Takeaway for Consumers and Businesses
This warning letter serves as a reminder of the FDA’s commitment to enforcing strict manufacturing standards to protect public health. For consumers, it underscores the importance of knowing the products you use meet rigorous safety and quality requirements. For businesses, it’s a wake-up call to prioritize compliance with federal regulations to avoid costly penalties and reputational damage.
Stay tuned for updates on how Horizon Tool Inc. responds and what this means for their products in the market. If you’re using AllShield E2 Sanitizing Hand Soap, consider reaching out to the manufacturer or checking for any recalls tied to this issue.
*Note: For more details, you can read the full FDA warning letter on the [FDA’s website](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/horizon-tool-inc-706567-06062025).*
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This version is concise, reader-friendly, and tailored for a blog audience, summarizing the key points from the FDA warning letter while emphasizing the implications for consumers and businesses. Let me know if you’d like adjustments, such as a different tone, length, or additional details!
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