IGMPI India



Hospira gets another Form 483

Hospira has now been caught in trouble due its manufacturing plant in Kansas. This plant has recently been brought to notice after the US health regulator, has observed three current good manufacturing practice (cGMP) violations.
All the while, the other plant of Hospira, the one at Rock Mount NC had been the main focus and was responsible for attracting Form 483. But this time, the plant at Kansas is found to be non-compliant. This plant is mainly focused on manufacturing injectable generics. Recently, another plant of Hospira, the one at Boulder, CO was under inspection and certain issues were observed, which resulted in two 483 observations.

Of late, many quality issues were also noted for Hospira, as regards the medical device industry, especially in the plant at Lake Forest IL. After this plant was inspected by the National Standards Authority of Ireland, there has been a peril that the ISO certification can get suspended. Additionally, there has been a product import ban on the products manufactured at this plant. A re-inspection by the FDA and meeting the regulator’s expectations can help in lifting the import ban.