Specify facilities and processes in LOAs to avoid SDRs, FDA counsel says
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.
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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.
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