Oct 21 (Reuters) - Eli Lilly and Co:
* ELI LILLY-1 MANUFACTURING PLANT UNDERWENT FDA GENERAL SURVEILLANCE INSPECTION TO EXAMINE ADHERENCE TO RIGOROUS GMP,QUALITY STANDARDS SET BY FDA
* FDA HAD SOME FINDINGS RELATED TO DATA HANDLING AND THUS RECEIVED AN OFFICIAL ACTION INDICATED (OAI) NOTICE
* ELI LILLY- ISSUES RAISED DURING BRANCHBURG INSPECTIONS HAVE CO'S FULL ATTENTION AND HAVE BEEN WORKING CLOSELY WITH FDA ON REMEDIATION EFFORTS
* ELI LILLY AND CO- HAS NOT RECEIVED WARNING LETTER OR OTHER ENFORCEMENT LETTER FROM THE FDA RELATED TO THIS MATTER
* ELI LILLY- CONFIDENT THAT THE ISSUES RAISED DURING THE BRANCHBURG INSPECTIONS DID NOT IMPACT PRODUCT QUALITY OR PATIENT SAFETY
* ELI LILLY- HAVE ENGAGED INDEPENDENT CONSULTANT TO REVIEW CO'S DETAILED BRANCHBURG MANUFACTURING AND QUALITY RECORDS FOR BAMLANIVIMAB Source text: https://bit.ly/3dRWB1W Further company coverage: