4. Failure to review, evaluate and investigate, unless any such investigation has been performed for similar complaints and another investigation is not necessary, any complaint involving the possible failure of a device, labeling or packaging to meet any of its specifications, as required by 21 C.F.R. § 820.198(c). Specifically,
a. Complaint 1269 initiated on 01/27/10 indicates patient died on 12/24/09 from multiple system failure due to sepsis. Upon review of one of the associated lots record (09MUV007), it was observed that there were analytical Out of Specification (OOS) test results for (b)(4) and a Material Deviation Report for the bioburden testing for this lot. Your investigational report failed to acknowledge these deficiencies.
b. Complaint 1663 involving a patient death was initiated on 01/31/12 and indicated BioGlue was not very viscous and was running deeper into the lumen. Upon review of DHR for the associated lots, syringes were rejected due to particulates for Lot Numbers 11MJX009 and 11MJX015 during filling of the 10 mL BioGlue syringes. The First Re-inspection for 11MJX015 showed that 61 out of (b)(4) syringes were rejected. The First Re-inspection for 11MJX009 showed that 49 out of (b)(4) syringes were rejected. An investigation was not generated for these two lots, and the re-inspection of the affected BioGlue did not document the reason for the rejected syringes.
c. Complaint 1278 reports Aspergillus was identified on a pre-implant culture of a pulmonary branch patch, (b)(4) that was tested by the customer (hospital). Review of the firm's environmental data finds that monthly environmental monitoring was not performed in the dissection room (TPL 1131) as required. A CAPA was completed for the deficiency. Environmental data for the monitoring period prior to dissection date recovered fungi, Bacillus, and Staphylococcus in air samples taken under passive conditions in the firm's dissection room. However, this info