Let's review the following (worst case) scenario:  You received a Warning Letter following an inspection from the U.S. Food and Drug Administration (FDA).  Most likely, this letter will detail those observations that you and your team "failed" to address in your initial response to form FDA 483 and, in most cases, the letter will include suggestions that will help you to comply with Federal Regulations.  One of these suggestions is to hire a cGMP consultant to assist your company in meeting cGMP requirements.

First and foremost, you should treat your Warning Letter with the highest importance.  But why? you may wonder.  Well, because this letter is coming directly from your most important customer, the FDA.  A consultant will help your company to navigate through the web of federal regulations and clean your path to welcome current and prospective clients.  Not being perfectly in compliance with these regulations pose a high risk to your organization to lose everything! It is...

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