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Specify facilities and processes in LOAs to avoid SDRs, FDA counsel says
Summary
FDA OPQ explained that LOAs must specify facilities/processes when applicants do not use every facility in a DMF; amending LOAs can resolve inspection or scope mismatches preventing approval.
Johnson used a hypothetical example to show how a lack of specificity in an LOA can trigger review problems. In her scenario, an API holder added a second manufacturing facility that had never been inspected; because the LOA did not restrict the authorized reference to facility 1 only, the FDA assumed the applicant used both facilities and issued a site deficiency review (SDR) or similar action until the LOA was amended.
She said DMF holders can amend LOAs to restrict authorization — for example, to say an applicant will only use API from facility 1 — and that after such an amendment, the applicant could be approved even though the second facility remained uninspected. Johnson cited the FDA Guidance for Industry (2019) as instructive on this point: "if you don't specify that, we assume the entire DMF is being referenced for every application."
