1. HBW Insight
  2. >>Health
  3. >>Policy & Regulation
  4. >>Compliance

Homeopathic Nasal Spray Firm Warned About Microbial Contamination Needs GMP Remediation

 
• By Malcolm Spicer

FDA advises additional recalls of Green Pharmaceuticals’ SnoreStop NasoSpray could be needed. Agency’s testing showed a batch of SnoreStop NasoSpray is adulterated because “it consists in whole or in part of any filthy, putrid, or decomposed substance.”

Shutterstock

The first US homeopathic firm to receive a warning since the Food and Drug Administration published a final guidance on regulating Rx and OTC products in the category likely would have attracted the agency’s scrutiny independent of the guidance.

The FDA Office of Regulatory Affairs’ Division of Pharmaceutical Quality Operations IV advised Green Pharmaceuticals Inc., of Camarillo, CA, on...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Compliance

FDA Warns Whoop BPI App Is Unauthorized Device; Firm Says Wearable Is A Wellness Tool

 
• By Brian Bossetta

Recent FDA warning letter claims Boston firm specializing in wearable technology marketed a blood pressure device without agency approval, but the company rejects the assertion and says the agency is out of step with federal regulations.

Remote Regulatory Assessments Become Swiss Army Knife For US FDA’s Oversight Of Facilities

 
• By Malcolm Spicer

“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.

Paying User Fees Not A Priority For Many OTC Monograph Drug Firms, First Arrears List Shows

 
• By Malcolm Spicer

The 1,383 entries on OMUFA arrears list for facility registrations from FY2021 through FY2025 on FDA’s list exceeds its estimate of 1,134 entities subject to the fee for FY2025.

FDA Draft Guidance Waves Green Flag On Changing Color Additives For Drugs In US

 
• By Malcolm Spicer

In a nod to drug manufacturers’ potential interest in moving to natural alternatives for petroleum-based synthetic dyes the agency intends to remove from use, document explains process for asking for approval for “any dye, pigment, or other substance that can impart color to a food, drug, cosmetic,

More from Policy & Regulation

House Health Subcommittee Members Agree OMUFA Crucial, Split On FDA Staff Cuts’ Impact

 
• By Malcolm Spicer

Subcommittee members aren’t on same page about whether FDA staff cuts ordered by the Trump administration will prevent the agency from fulfilling its responsibilities for the OTC drug sector.

House OMUFA Reauthorization Bill Takes On Clarifying Standards For Tests To Meet GRASE

 
• By Malcolm Spicer

Health Subcommittee will discuss reauthorizing OMUFA during a hearing on how to “maintain and improve” the public health workforce and rural health as well as access to OTC medicines.

Pharma Deutschland Seeks To Enter Urban Wastewater Legal Dispute

 
• By David Ridley

The Urban Wastewater Treatment Directive “in its current form, is at an end,” insists Pharma Deutschland CEO Jörg Wieczorek. To put the directive to bed once and for all, the association has applied for leave to intervene in the ongoing EU legal battle in its own right.