This is resulting from an inspection of the facility on South Delaware Street, Indianapolis, FEI #1819470, which began on September 11, 2023. FDA personnel spent five (5) days on-site.
The 483 document is available for purchase/download here.
The 483 contains five observations, ranging from failure to ensure prescribing HCPs are properly certified, to failure to ensure that each patient receiving the drug has evidence or other documentation of safe-use conditions.
There were two FDA Investigators involved:
- Dina Tallman
- Jennifer Kemp
Some of Lilly’s response is highlighted in this Endpoints article.
Enpoints notes that: “Eli Lilly shipped its schizophrenia drug to uncertified pharmacies and was not adhering to established safety procedures“.
Lilly, in a statement to Endpoints, said that “we work diligently with the FDA to ensure compliance with stringent regulatory requirements, including any required drug safety programs.”