Brief: Fagron Update On Fda Communication Regarding 2025 Inspection
15/05/2026 06:40
May 15 (Reuters) - Fagron NV FAGRO.BR: COMPANY RECEIVED A WARNING LETTER FROM FDA ON MAY 12, 2026 ASSOCIATED WITH DRUG PRODUCTS PRODUCED AT FACILITY USING IV BAGS SUPPLIED BY A THIRD-PARTY MANUFACTURER PRODUCTION AT BOSTON FACILITY CONTINUES AS NORMAL, CONTINUES TO SUPPLY ITS CUSTOMERS WITH NO MATERIAL IMPACT ON BUSINESS COMPREHENSIVE REMEDIATION PLAN IS IN PLACE, THE COMPANY WILL RESPOND IN FULL TO THE WARNING LETTER WITHIN THE TIMEFRAME SET OUT BY THE FDA SUPPLIER HAS IMPLEMENTED CORRECTIVE ACTIONS HAS NOT IDENTIFIED ANY FURTHER RELATED DEFECTS THROUGH ITS INCOMING INSPECTION REGIME Source text: ID:nNDL38zHmL Further company coverage: FAGRO.BR (Gdansk Newsroom) ((gdansk.newsroom@thomsonreuters.com ; +48 58 7785110;))