Are you destroying your documents properly?

Are you keeping a log of the documents that are being destroyed?

A company recently received this 483 observation: 

…..The responsibilities and procedures applicable to the quality control unit are not fully followed.

Specifically, your QA technicians and other individuals were recorded destroying and altering records pertaining to commercial batch manufacturing immediately prior to this regulatory inspection.  The loss of data and documents are evidenced by a review of your firm’s Closed Circuit TV.  We identified the following …..

Your firm’s Quality Manager stated that your firm has failed to maintain a log of what documents had been shredded.

For more details on this observation as well as other observations pertaining to Manufacturing Controls see Issue 1017 available today.  It features observations pertaining to Packaging and Labeling on our rotating page 3 topic as well as Laboratory Controls and Manufacturing Controls.

Stay in Compliance! Subscribe today!

Stay in Compliance!

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!

LEARN MORE
About GMP Trends

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

Available Reports
Stay in Compliance!

Sign up for free highlights and updates from GMP Trends


Report Categories
Recent Posts
Recent Comments
Archives
Categories
Meta

Become A Subscriber And Stay Ahead of the FDA

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!

SUBSCRIBE NOW