FDA Fields Tough Questions About Inspections, Challenges Pharma to Be Open, Honest

Sometimes it is physical attributes or it can be a chemical property like another component of an excipient that causes dissolution problems. You have to know what it is that makes your excipient or active ingredient tick, and understand what physical attributes you need to check for or evaluate your supplier for.

You can use third parties such as IPEA and Rx360 as long as they are qualified.

Q: After initiating inspection it has become more common for investigators to request that documents be faxed or emailed to them at their office for review rather than returning to the site to review them at the facility.  Sometimes the document requests are voluminous and the inspector only returns to the site to read and issue the 483. Is this practice condoned by field office management? Is it consistent with the statutory requirement that inspections proceed in a reasonable manner?

Barry Rothman: We certainly do not condone that kind of activity. Reflecting on it though, we live in a different world today. We are living in this new generation, with what I once called “electronic-based” investigators who grew up in the Twitter age and are used to and may prefer electronic communication media.

It is our responsibility in field management to educate our investigators how to conduct an inspection in a reasonable manner. It is industry’s responsibility to let us know when investigators are [over-relying on electronic and digital communication].

I know there’s a fear of retaliation, but you really need to communicate with FDA management. Several years ago, I received a complaint about an investigator, but this communication came only after several years of a series of inspections that this investigator had been conducting.

We knew nothing about what was going on in the field because we didn’t see it. As in any environment, individuals don’t always act the same way in the field as they do when [management is] there, or when they are in the office.

 Once we found out about it, we met with the company, interviewed them, took affidavits, and that investigator was removed. There was no retaliation against that firm and we had a good discussion about how much we appreciated their willingness to come forward.

We do not condone faxing or emailing as primary means of communication, but there may be situations where a faxed document or email document may be sent in. That normally will be during a recall event, you could send it to an investigator but you may send it to the R&E coordinator in the District Office.  In fact, that may be the most efficient way to provide distributor lists and that kind of information, but during the course of an ongoing inspection, that is not appropriate.

Some documents may be requested before the inspection.

Rick Friedman: [Using that approach for some documents] could even shorten the time required for inspection. You want inspectors visiting your site to read up on [background information] and understand your processes before they are in your conference room.