The FDA’s recent and ongoing focus on over-the-counter (OTC) drugs and other health products intensified with the agency issuing warning letters to four companies with very similar citations.

The agency referenced these findings to point out its industry-wide concern for violations it said puts consumers at significant risk. These include insufficient quality controls for potentially hazardous products and skipped safety tests that have led to potentially harmful contamination in multiple products.

While these latest crackdowns target producers of homeopathic products specifically, (an area which began attracting greater attention from regulators back in 2015) the broader OTC manufacturing field has come under greater oversight, as evident by recent inspection and enforcement trends.

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As of March 29th, 2019, FDA has issued two draft guidances relevant to inspections of domestic and foreign medical device establishments.

The first, issued by FDA’s CDRH in February, identifies a new standard mechanism for device establishments to request nonbinding feedback on actions proposed to address FDA Form 483 observations.

The second, issued by FDA in March, seeks to implement uniform processes and standards for FDA inspections of domestic and foreign device establishments.

Below, we’ve summarized the key takeaways from both of these draft guidances along with general advice for contextualizing and considering action.

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In September of 2018, FDA's CDER published and implemented a new Manual of Policies and Procedures (MAPP) describing the Site Selection Model (SSM) used to prioritize manufacturing sites for routine CGMP surveillance inspections under the Agency's 'risk-based' approach.

As stated, FDA aims to use this model to make the most effective and efficient use of limited resources in an increasingly global manufacturing industry.

According to the Inspection MAPP, while FDA has officially used a 'risk-based" approach for prioritizing pharmaceutical drug manufacturing inspections since FY2005 (which was codified in 2012 with Section 510(h) of the FFDCA, replacing the prior statutory two-year inspection cycle), data from FDA's Inspection Data Dashboard reveals that many establishments are still inspected every two to three years.

This guide offers a clear and simple summary of the background surrounding these policies, what the stated risk factors are, and what FDA-regulated manufacturers can do to prepare based on the information available.

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In January 2019, FDA Commissioner Scott Gottlieb confirmed through a series of tweets and other statements that manufacturers should expect FDA inspections of generic drug plants to increase and become more thorough throughout the year as part of an effort to implement its "risk-based" inspection model.

According to Gottlieb, the agency has made a concerted effort to inspect every generic facility, which has allowed for "a very sophisticated risk-based model to target future inspections; making our inspectional work more focused, more efficient, and more effective.”

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Life science validation projects –– particularly those in heavily regulated industries like medical device and pharmaceutical manufacturing –– often require a multi-disciplinary team of professionals sourced from internal functional areas as well as outside resourcing firms capable of filling internal gaps and bringing firsthand experience and specialized expertise to bear.

The practice of using multi-disciplinary teams to support Quality System activities including the Qualification and/or Validation of new or modified facilities, systems and processes has become a cGMP expectation of the FDA as well as many other regulatory agencies in ICH markets.

Regardless of the specific type of validation work being done, quality outcomes are increasingly reliant on creating these cross-functional teams that are built and managed in a way that recognizes the abilities, incentives, and limitations of each stakeholder and points them toward the same objective.

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