rsmith
GLP-1 Apprentice
Attention Wegovy/Ozempic fans.
Novo is the first GLP manufacturer and previously asserted that compounded versions of it's GLPs are dangerous because of risk for contamination/impurity.
The industry may recall that the aforementioned plant reportedly had unaddressed cases of contamination by “atypical extrinsic particles,” including cat and human hair that were found in vial stoppers, and reports of pest infestations found in classified areas.
Got hair?
Since this time, approximately 20 additional deviations related to hair contamination during 100% manual visual inspection have occurred.
www.pharmaceuticalcommerce.com
Novo is the first GLP manufacturer and previously asserted that compounded versions of it's GLPs are dangerous because of risk for contamination/impurity.
The industry may recall that the aforementioned plant reportedly had unaddressed cases of contamination by “atypical extrinsic particles,” including cat and human hair that were found in vial stoppers, and reports of pest infestations found in classified areas.
Got hair?
Since this time, approximately 20 additional deviations related to hair contamination during 100% manual visual inspection have occurred.
Novo Nordisk’s Bloomington Plant Receives FDA OAI Designation Following Contamination and Compliance Issues | Pharmaceutical Commerce
The fallout is impacting partners Scholar Rock and Regeneron, both of whom have pending regulatory applications tied to the facility.
