Welcome to the Horizon Phoenix Group LLC – cost effective, agile and experienced consultants and lead auditors helping medical device, biotechnology, in vitro diagnostic and pharmaceutical manufacturers get their products into the market place as quickly as possible. MORE...

Help! The FDA is mad at me!

Nothing is as disconcerting, expensive and time consuming as an FDA 483, Warning Letter, Field Correction or Recall.

When you bring Horizon Phoenix experts in to assist you in these situations three very important things happen.

1) You can go back to running your company, making safe products and expanding your market share.

Second, 2) The issues are not only adequately and appropriately addressed, but we also ensure the corrective/preventive actions implemented are effective and achieve desirable results. But most importantly,

3) We restore your working relationship with USFDA.

You cannot talk your way out of these kinds of problems – you need solid, effective actions that reflect great integrity on your operations and product line. Horizon Phoenix experts have been there before, we know what to expect, we know what works and what doesn’t.

Horizon Phoenix experts, 25 years experience in putting clients on the cutting edge and keeping them off the cutting block!

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