Don’t Fight the FDA Auditor! FDA Issues Guidance on How to Avoid Inspection Problems

Don’t Fight the FDA Auditor! FDA Issues Guidance on How to Avoid Inspection Problems

July 17th, 2013 // 2:43 pm @ jmpickett

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FDA has been ramping up its efforts to inspect drug facilities in the last three years or so. Some of the largest pharmaceutical companies have had cGMP inspectors at many of their sites. Drug compounding pharmacies are getting more scrutiny due to a very serious fungal meningitis scandal. FDA audit staff is being increased at many foreign sites, such as China and India. Overall, more 483s and warning letters are being issued.

But, what happens if the drug maker pushes back at the FDA inspector? What if the company is slow to make a document or a facility available for review. Or, the company will not allow the FDA auditor to access some of the rooms in the building. In the regulatory world, this behavior is very troubling and can cause FDA to state that your drug is adulterated.

Naturally, not cooperating during a cGMP inspection is going to get you more FDA scrutiny, and can lead to an FDA 483 or warning letter. However, FDA does want to help you to avoid these sorts of situations. So, FDA came out with some new guidance this week that details some of the situations that can get you in trouble during an FDA inspection.

New Webinar – The Hitchhiker’s Guide to 483s and Warning Letters

A good deal of the information in the draft guidance is common sense. But the following is what FDA states regarding a delay in an inspection that was announced in advance, that can result in your drug being called adulterated:

• The facility does not agree to the start date for an inspection, and it does not provide a clear explanation on why
• After scheduling the inspection, the facility asks for another start date and does not give a good reason
• The designated contact at the company does not respond to FDA requests

As you can surmise, these types of behavior can get you into serious problems with FDA during an audit. Some of the other problems that FDA mentions in the guidance:

• Drug facility does not let FDA into part of the facility until a future time, even if the area is operating, and the area is one that FDA has the legal authority to inspect
• The FDA auditor is left in a room without proper access to documentation or responsible employees for a long period, in such a way that makes it difficult for FDA to complete the inspection.

FDA states that your drug can be considered adulterated if during the audit, the inspector asks for records that FDA has the right to review during a reasonable period of time. However, the facility does not give the records during the time frame and does not provide an explanation.

These are red flags that cause problems and regulatory action:

• The facility does not let FDA schedule an audit
• It does not let the FDA start the inspection on time even when it was scheduled in advance
• It does not let the auditor conduct the inspection because certain employees are not there
• It does not let the inspection take place because it alleges falsely that drugs are not made there.

Note that limiting an audit is another bad idea that can lead to a 483 or warning letter. What is limiting?

• The facility stops manufacturing during the inspection with no explanation
• Direct observation of manufacturing processes is limited without explanation
• Direct observation is limited to only parts of the manufacturing process
• Entry is restricted to a facility without justification
• Staff forces FDA to leave before the inspection is finished

What is limiting the agency’s access to company records? This is, according to FDA, when the company will not let the FDA inspector go over the shipping records; or if the facility gives some of the records but not all of them;  or if many of the records are redacted to a degree they cannot be analyzed.

If you want to know what FDA considers giving an inspector a hard time:

• The company will not allow the inspector to enter the facility or some parts of it – such as not unlocking doors or taking actions that are needed to allow access
• FDA tries to contact employees and they do not respond
• The company does not answer calls from the inspector who is at the plant

While this is just a draft guidance, we see it as somewhat of a warning shot from FDA!

Looking for tips on how to ace your next FDA inspection? Check out this highly informative and entertaining webinar on cGMP inspections.