Man Admits Falsifying Blood Data

A San Juan Capistrano man pleaded guilty Friday to falsifying records to regulators on blood and plasma he collected and sold at his Orange County laboratory.

Federal prosecutors said there was no evidence that any blood products distributed by Craig H. Petrik’s company were contaminated. As part of the plea agreement, officials refused to discuss what might have prompted Petrik to submit false records to the Food and Drug Administration during a 1997 inspection of the company’s Orange facility.

“Were any of his products contaminated with infectious diseases? There is no evidence to suggest that,” said Assistant U.S. Atty. Carmen R. Luege.

The FDA suspended the license of Petrik’s company, Biosera Inc., in October, 1997, after officials, during a routine inspection, became suspicious that he had tampered with logs used to track all blood products. The company closed a short time later.

The FDA requires detailed records for all red blood cell donations and their disposition, and about the plasma collected from donors, in case any products are later determined to be contaminated. Recipients of contaminated products can then be notified, Luege said.

Biosera separated red blood cells from donated blood and injected them in plasma donors who were found to produce certain antibodies in their blood. This plasma was then sold for use in manufacturing drugs or to test medical devices.

In his plea agreement, Petrik admitted that the sensitive logs contained false information about the disposition of a particular batch of red blood cells, Luege said.

Petrik’s attorney, John Potter, could not be reached for comment Friday.

The charge of making false statements to the FDA carries a maximum penalty of five years in federal prison and a fine of up to $250,000. Sentencing was set for April 30 before U.S. District Judge Gary L. Taylor.