FDA begins follow-up inspection at Xspray Pharma manufacturer NerPharMa over compliance issues

• The FDA has begun an unannounced follow-up inspection at Xspray Pharma’s contract manufacturer NerPharMa in Italy over previously identified manufacturing compliance issues.
• Approval of Dasynoc and Nilopki remains conditional on satisfactory current good manufacturing practice status at NerPharMa.
• Plans to resubmit both drug applications in the fourth quarter of 2026 remain unchanged; resubmissions can proceed independently of NerPharMa’s compliance status.
• The FDA generally aims to notify facilities of final inspection classifications within 90 days of completing inspections.

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