Are they under lock and key?
A company recently received this 483 observation:
…..Procedures describing in sufficient detail the controls employed for the issuance of labeling are not written and followed.
Specifically, there were no approved written procedures for the receiving, inventory, issuance and reconciliation of labels used at your facility. You did not have access control procedures, and you did not secure the labels under lock and key.
For more observations pertaining to labeling controls see Issue 1025 available today. It also has observations pertaining to manufacturing controls, laboratory controls and medical device manufacturing controls.
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