Business Owner to FDA Auditor: Quality Policies Are All in His Head

Business Owner to FDA Auditor: Quality Policies Are All in His Head

October 19th, 2011 // 12:42 pm @

Some people can remember anything. Take James Jacobson. He owns X-Ray Support, which sells dental x-ray automatic film processors. No, this is not a prescription drug or anything close. But consider his response to an FDA inspector who visited his Spokane Valley, Washington, facility last May. The answer is just the sort of reply to guarantee further attention from the agency.

To wit, the inspector noticed that X-Ray Support failed to create or establish a variety of procedures, such as for implementing corrective and preventive actions; controlling the design of its product to ensure requirements are met; controlling documents; conducting quality audits and maintaining a quality system record. In other words, an awful lot of paperwork was lacking.

But why? The inspector asked Jacobson about the numerous failures and his response is either a curious form of braggadocio or simply foolishness. “Upon request by the investigator for the above referenced procedures,” the FDA writes in its September 23 warning letter, “you indicated the requested procedures were located in your head.”

Really? Well, what better way to ensure that important information is not pilfered or hacked or conveyed to a competitor than to keep it where it will not easily leak? Jacobson, however, did not remember everything. The FDA letter notes that X-Ray Support failed to file annual registration and listing requirements for four consecutive years, from 2008 through 2011.

Jacobson may have forgotten something else. According to the letter, the agency received an e-mail last May indicating X-Ray Support would no longer build its ImageMax product and requested the company be removed from an FDA list. However, the FDA checked the website in June and September and found the device was for sale. So the procedures were all in his head, but not what he wrote to the FDA?

Source: Pharmalot


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