The FDA issued a second complete response letter (CRL) to Seikagaku for its resubmitted BLA for condoliase (SI-6603), a therapy aimed at radicular leg pain associated with lumbar disc herniation. Seikagaku said the agency cited unresolved deficiencies tied to drug substance manufacturing after a prior inspection, and it also identified new deficiencies during a cGMP inspection of the contract manufacturing facility for the drug product. The second CRL underscores how manufacturing controls and facility quality remain gating items for reviews, even after resubmission, and it can push companies back into remediation and revalidation work before any potential approval path reopens.