FDA’s Office of Compliance Offers Inspection Tips

Any employee at a device company who has the power to hire, fire or buy, should be prepared to speak to investigators during a facility inspection.

That’s the advice of Randy Pack, director of compliance at the FDA’s Baltimore District Office, who added that inspectors want to be in and out of a facility as quickly as possible, a hope shared by company management.

Companies can make that happen by providing necessary documents quickly and being upfront about issues, Pack said last week at the Regulatory Affairs Professionals Society Regulatory Convergence Conference in Baltimore, Md.

If an inspector makes a large request, such as asking for all complaints dating back to 2003, Pack advises companies to let him or her know that it will involve gathering together a lot of information. Provide the inspection an approximate amount of documents the inspector should expect, instead of just handing over a stack of documents.

Many investigators have expressed frustration about the amount of misleading information provided by device manufacturers.

For example, documents thrown together at the last minute stick out as red flags, indicating that something is amiss. Falsified documents also serve as a warning sign, Pack said.

Companies that discover an employee has falsified information should immediately inform the FDA or an inspector and provide planned corrective actions.

Firms also should inform their district offices if they are conducting layoffs before a scheduled inspection, so investigators have a heads up in case employees who are losing their jobs provide information that shines a negative light on the company.

Investigators also have the right to take photos during an inspection. However, attempts will be made to capture the information by other means, he said.

Finally, don’t automatically admit someone with an FDA badge claiming to be there for a domestic inspection. That person must show an FDA Form 482, a notice of inspection.

Those who do not should be politely, but firmly, told that he or she does not have the right to conduct an inspection without that form.

The notice of inspection requirement does not apply to foreign facilities. — Kellen Owings