The Verification Test for the Programming/Verification of code chips (no document control number) dated 4/21-22/2005 is inadequate in that: i. There is no document control number . ii. Step 6 of the verification test requires a repeat of the step [redacted] times, [redacted] for a total of sample size of [redacted]. Instead, the protocol/raw data indicates only [redacted] blank code chips were utilized to conduct the programming/code chip download challenge (i.e., [redacted] chips for each of the [redacted] code chip types). iii. Upon download of the code chip information, there was no verification activity to ensure that the integrity of the performance data, which is unique to each lot code, was not compromised. iv. The raw data associated with the download challenge/programming of the [redacted] chip is missing from the Programming/Verification of Code Chips documents.
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