STAT+: FDA warns Aspen Pharmacare, Africa’s biggest drugmaker, over sterility issues at a key plant
The FDA has warned Aspen Pharmacare, the largest pharmaceutical company in Africa, over sterility issues at a key plant.
The U.S. Food and Drug Administration has warned Aspen Pharmacare, the largest pharmaceutical company in Africa, that it had failed to take sufficient steps to prevent microbial contamination at a key facility that makes eye drops and many other medicines that require sterile production.
In a Feb. 24 warning letter, released publicly Tuesday, the agency noted that Aspen — which sells its own drugs and develops and manufactures medicines for other companies — also failed to establish scientifically sound laboratory controls to ensure products conform to appropriate standards for strength and quality.
The warning follows an inspection last September at a sterile manufacturing plant in Gqeberha, South Africa, where the agency found various quality control problems. These included inappropriately designed equipment for manufacturing or packaging products and laboratory records that did not include complete data from tests.
