Aerscher owner ticked off at FDA validation desires.

Aerscher Diagnostics, Chestertown, MD, was cited for process validation deficiencies in a May 18 letter following an April 21-23 audit of the firm's IVD production by the Baltimore District Office.

FDA found the firm's April 25 response deficient because there was no listing of specific actions that would be taken to correct the deficiencies and estimated time to complete the corrections.

Company owner Dr. Robert Schreiber, M.D., owner, expressed frustration with the inspection process in an Aug. 13 interview. "They said I have to do validation," he said. "This is purely a one-man operation. I do everything. For me to write down validation procedures makes no sense. I'd be writing down procedures for myself."

"I'm not even small," the doctor lamented. "I'm a minuscule company."

Schreiber said neither FDA nor 10 mechanical consultants he has hired understood his device. "They [FDA] would ask 'how do you know the temperature is working?' I would tell them," he recalled.

Schreiber also said FDA did not say how many runs to do for validation. "They just say get this book. They told me publications to buy. They said: 'you can get this through the Internet', but it doesn't apply to your particular problem. It doesn't say anything specific."

Schreiber said the big problem the agency had was with his documentation. "I do document things, but I would have to write a book to tell how this machine works. I could write a summary but it doesn't tell anything. I'm changing the machinery a lot. I can't write down everything I do. It's an enormous amount of paperwork to get to where I've gotten."

The physician also said he had to hire a consultant to reply to the 483, primarily to "interpret the jargon" in the agency's observations.

Schreiber lamented that he felt unable to communicate freely with the investigators. "It would be nice to have free communication with them without your words being used against you," he added. "FDA generally is not helpful in guiding you at all. They say there has to be someone trained in statistics, some trained in quality standards. They're applying the same standards to me as big companies."