Background and Current Status
PureChemPros believes in transparency with our customers, vendors, and business partners. This page provides context regarding an FDA Warning Letter issued to PureChemPros in 2023, the circumstances that led to it, and the corrective actions we subsequently took.
Our Hand Sanitizer Production During COVID-19
During the COVID-19 pandemic, the United States experienced significant shortages of hand sanitizer.
In response, the U.S. Food and Drug Administration (FDA) introduced temporary policies that allowed companies that were not traditionally drug manufacturers to produce hand sanitizer products to help address the nationwide shortage.
PureChemPros was one of the businesses that entered the hand sanitizer market during this period. We produced hand sanitizer as part of the broader effort by American manufacturers and suppliers to increase the availability of these products during the pandemic.
As the pandemic emergency evolved, FDA transitioned away from these temporary policies and returned hand sanitizer manufacturing to the standard regulatory framework applicable to these products.
FDA Inspection and Warning Letter
Following this transition, FDA conducted an inspection of the PureChemPros facility.
The inspection identified deficiencies relating to the regulatory and manufacturing requirements applicable to our hand sanitizer operations under the standard regulatory framework.
FDA also reviewed the PureChemPros website and identified language associating certain hydrogen peroxide products with human applications. FDA determined that some of these claims caused the products to be subject to additional FDA drug requirements.
PureChemPros began implementing corrective measures following the inspection and communicated with FDA regarding those efforts.
FDA subsequently issued a formal Warning Letter to PureChemPros in September 2023 addressing the hand sanitizer manufacturing issues as well as certain hydrogen peroxide marketing claims.
Corrective Actions Taken by PureChemPros
PureChemPros took the FDA’s concerns seriously and implemented corrective actions to address the matters identified during the inspection and in the subsequent Warning Letter.
Rather than undertake the additional regulatory requirements necessary to continue operating as a manufacturer of an FDA-regulated hand sanitizer product, PureChemPros elected to discontinue the hand sanitizer business entirely.
Our corrective actions included:
Discontinuing hand sanitizer production and sales.
PureChemPros ceased manufacturing, diluting, bottling, and selling hand sanitizer.
Removing our hand sanitizer FDA listings.
The hand sanitizer product listing and associated establishment registration were removed from FDA’s CDER Direct system.
Removing hand sanitizer from our sales channels.
Hand sanitizer products were removed from the PureChemPros website and our Amazon listings.
Reviewing hydrogen peroxide marketing and website content.
PureChemPros conducted a comprehensive review of our website and removed or revised content identified as associating our hydrogen peroxide products with human applications.
Focusing our product marketing on chemical applications.
Our hydrogen peroxide products are marketed as chemical products rather than as products intended to diagnose, treat, cure, or prevent disease.
Providing documentation to FDA.
PureChemPros submitted detailed written responses describing the corrective actions taken. We subsequently provided FDA with additional documentation and copies of revised product pages so the agency could review the changes we had implemented.
Where Things Stand Today
PureChemPros no longer manufactures or sells hand sanitizer.
Our business today is focused on supplying chemical products, and we have revised our marketing practices to remove the human-use claims identified by FDA in connection with our hydrogen peroxide products.
PureChemPros provided FDA with documentation of the corrective actions taken in response to the Warning Letter, including additional supporting materials and revised product pages.
The 2023 Warning Letter remains publicly available on FDA.gov as part of the agency’s historical enforcement records.
We provide this page so that customers, vendors, and business partners who encounter the historical Warning Letter can also understand the circumstances surrounding it and the actions PureChemPros took in response.
Moving Forward
The COVID-19 pandemic created an extraordinary environment in which businesses across the United States stepped forward to help address shortages of critical products. PureChemPros was among the companies that entered the hand sanitizer market during this period.
As FDA transitioned away from its temporary COVID-era policies and the standard regulatory framework again applied, our hand sanitizer operation faced requirements that differed substantially from the environment in which we originally entered the market.
Rather than continue in the hand sanitizer business, we discontinued those operations and addressed the additional concerns identified by FDA regarding the marketing of our hydrogen peroxide products.
The experience resulted in meaningful changes to our internal processes, documentation, regulatory awareness, and approach to product marketing.
We believe transparency is important. Rather than ignore the historical FDA correspondence, we want customers and business partners to have access to the broader context surrounding it and understand the corrective actions PureChemPros took in response.
PureChemPros remains committed to continually improving our operations and providing our customers with high-quality chemical products.