Keystone compliance cops

The Food and Drug Administration's right hand doesn't know what the left is doing, and despite the validity, the bureaucracy-mired agency recoils when questions abound.

Adven Medical Inc. (Lubbock, Texas) has worked closely with the FDA in what CEO Mark Aldana describes as cordial rapport aimed at ensuring cleaning, sterilization and validation protocols fell in line with current good manufacturing practices (cGMPs).

Aldana, to put it mildly, was sucker-punched with an FDA press release full of “false and inflammatory” information that sparked him to issue his own statement, a rather believable haymaker revealing apparent agency deception and incompetence. (See story, page 26.)

He certainly makes a case, and this isn't the first instance of FDA bullying.

The FDA action against Adven reeks of impropriety. A medical device re-processor, one that continually sought FDA feedback, was backstabbed by a self-effacing agency, where communication between offices seems to be non-existent. Moreover, actions against Adven do not mesh with the risk- and science-based goals outlined in the FDA mission to revamp cGMPs.

Life sciences companies are already weathering economic and political storms, and it is time to hold the FDA accountable for being the port that it has promised it would be.

Click here to enlarge image

Mark A. DeSorbo
Associate Editor

POST A COMMENT

Easily post a comment below using your Linkedin, Twitter, Google or Facebook account. Comments won't automatically be posted to your social media accounts unless you select to share.

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

NEW PRODUCTS

Dynaloy unveils safer cleaners
11/19/2014In response to evolving industry trends and customer preferences for products with better environmental, health, and safety (EHS) profiles, Dynaloy LLC is launching three...
Entegris' VaporSorb filter line protects advanced yield production
10/21/2014Entegris, Inc. today announced a new product for its VaporSorb line of airborne molecular contamination (AMC) filters. ...
Next-generation nanoimprint lithography technology
10/21/2014EV Group (EVG) today introduced its SmartNIL large-area nanoimprint lithography (NIL) process....