Former Lab Owner Gets Probation, Fine

A San Juan Capistrano man was sentenced Monday to five years’ probation and fined $30,000 for falsifying records to federal regulators on blood and plasma he collected and sold at his Orange County laboratory.

Craig H. Petrik, 44, former head of now-defunct Biosera Inc. in Orange, also was ordered by U.S. District Judge Gary Taylor to complete 250 hours of community service.

Petrik pleaded guilty to one federal charge in January, ending an investigation stemming from a routine 1997 inspection of his company’s facility by the Food and Drug Administration.

There was no evidence that any blood products distributed by Biosera were contaminated, Assistant U.S. Atty. Carmen R. Luege said. Petrik never disclosed to authorities why he falsified records.

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

The agency requires detailed records for all red blood cell and plasma donations and their disposition, in case any products are later determined to be contaminated. Recipients of contaminated products then can be notified.

Biosera separated red blood cells from donated blood and injected them in plasma from 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 pleading guilty, Petrik admitted that the sensitive logs contained false information about the disposition of a particular batch of red blood cells, Luege said previously.