Japan manufacturing-site findings

The laboratory sample preparation worksheets used for preparation of all samples in the laboratory do not have a system to control and record issuance of the worksheets or to identify issuance of multiple worksheets for the same sample preparation.

There is no data to support that the (b)used in the construction of production tanks, including the (b)(4) Tank, L Tank, (b)(4) Storage Tanks, and the [ (b) (4) Tank, used to produce all APIs manufactured at the site is not additive to the APIs.

Five out of five investigations into production deviations and laboratory out -of -specification results reviewed did not identify the true root cause and supported action to be taken to prevent a reoccurrence of the issue.

QC laboratory established written procedure for synchronization of laboratory instruments time with the actual time was not followed.

Microbiological laboratory lacked established written procedure for cleaning of incubators and labeling of d.

Validation of analytical methods is incomplete.