Greiner Bio-One North America did not complete validation testing or evaluate the effect of a manufacturing change, among other quality system letdowns, the FDA explained in an April 16 warning letter.
The FDA received responses on Jan. 7 and March 13 to the list of observations issued at the close of the Dec. 9-13, 2019, inspection at the firm’s Monroe, N.C., facility. However, the responses were not satisfactory.
Greiner Bio-One neglected to finish validation testing for the qualification of a new supplier it used in the manufacturing of its Vacuette brand blood collection tubes. The incomplete testing didn’t adequately evaluate the potential of the manufacturing change to the safety of the device prior to approval of the new supplier, the warning letter said.