Remote Regulatory Assessments (RRA)

Remote Regulatory Assessments

A Remote Regulatory Assessment is a necessity created by the COVID-19 pandemic. Ordinarily, FDA would conduct an on-site audit as part of a routine inspection for pre-inspection prior to approval. A pre-inspection is required for some product types. For example, under 906(e)(1) of the The Family Smoking Prevention and Tobacco Control Act, a tobacco product is considered adulterated if the methods used in, or the facilities or controls used for, its manufacture, packing, or storage do not meet Current Good Manufacturing Practices (cGMPs). Even though, the FDA has not yet issued these for tobacco and deeming products, the FDA is expected to roll-out Tobacco Product Manufacturing Practices (TPMPs), that will be the cGMPs for tobacco. An inspection of the manufacturing facilities as well as clinical and non-clinical laboratories to assess compliance with cGMPs, and the forthcoming TPMPs, will be a critical part of the FDA’s substantive review of all submitted PMTAs.

Currently, the FDA is now beginning to place many Pre-Market Tobacco Applications (PMTAs) for vape, e-liquids, etc., into scientific review, which will trigger an RRA of the manufacturer as the first step. The audits are intensive. They consist of an initial 3 to 4 hour meeting followed by three follow-up meetings that vary in length. The FDA provides an extensive list of questions focused on validation, quality controls, design specifications, quality agreements, and so forth.

Taking the manufacturer through mock audits has been invaluable to navigate language barriers and clarify misunderstandings about what FDA is asking for. The remote aspect, conducting the meeting by WebEx, is new but the regulatory assessment part is the same. An assessment can take a “bottom-up” or a “top-down” approach. By looking at one or more instances of quality problems, such as nonconforming reports, failure to capture complaints, etc., FDA will work its way back through the firm’s quality system. This method has been helpful in zeroing in on specific problems, and evaluating a firm’s actions relating to those problems. However, with the “top-down” approach, FDA is looking at the firm’s “systems” for addressing quality before it actually looks at specific quality problems. In the “top-down” approach, FDA will “touch bottom” in each of the subsystems by sampling records, rather than working its way from records review backwards towards procedures.
The “top-down” approach begins each subsystem review with an evaluation of whether the firm has addressed the basic requirements in that subsystem by defining and documenting appropriate procedures.

And RRA has no impact on which approach FDA may take.

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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