The FDA has issued LifeCell, which develops and sells tissue grafts and blood cell preservation products, a warning letter for failing to adequately validate its packaging procedures and not ensuring that GMP requirements continue to be met.
The letter states that potential sealing problems found in the firm’s Strattice device, used for inguinal hernia repair, were not documented in the company’s records.
During a June 10 through Sept. 3 investigation of LifeCell’s Somerville, NJ, plant, the FDA found that four lots of Strattice devices had failed tests for inner pouch strength and several other lots failed mechanical testing.
The FDA cited the firm for not identifying the root causes of the failures or assessing the training needs of its operators. Also, the firm did not verify that the corrective and preventive action (CAPA) it took was effective. Because of these oversights, the FDA noted that additional lots later failed in mechanical testing.
LifeCell said it would develop new procedures to establish a quality reviewer checklist, which will apply to data collected by R&D, to support quality decisions.
The FDA said it will evaluate the new procedures when they are complete.