Do you have strict control over your labels?

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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GMP TRENDS is a publication for the pharmaceutical and medical device industries, trending observations made by FDA investigators during GMP inspections throughout the world.

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To get the most out of GMP Trends®, sign up to one of our subscription packages for valuable, up-to-date information you won't find anywhere else! Every subscription provides the most frequently cited FDA 483 observations taken from recent FDA Inspections. The non-essential information is redacted to streamline the facts in an easily readable format. Join the thousands of professionals who rely on GMP Trends® to keep them informed of the latest FDA Enforcement Trends!

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