Coulston on the Ropes Again

The Coulston Foundation (TCF) continually allows the grossly negligent deaths and inhumane treatment of chimpanzees for whom it is responsible. Now TCF is facing a new set of problems from the Food and Drug Administration for violations of Good Laboratory Practice (GLPs) regulations.

GLPs are in place to regulate experiments “to assure the quality and integrity” of the laboratory practices for research involving “food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products.” Just as TCF repeatedly has violated the Animal Welfare Act, now it has been cited for nearly 300 violations of GLPs.

Infractions from the FDA inspection report include:

…not all studies had an approved written protocol that clearly indicated the objectives and all methods for the conduct of the study.

There is no assurance that all the surgical procedures were approved….

The identity of a study animal on a [xxx] report dated [xxx] was corrected from [xxx] using a scrap piece of paper. {[xxx] indicates redacted, or blacked out, information}

Temperature monitoring records are incomplete….Humidity is not monitored during the entire study.

The animals were fasted the day prior to any study activity. There was study activity daily for the first [xxx] days of the study, and weekly thereafter. The animals experienced decreased appetite and diarrhea. No animals were taken off the study for health reasons.

A certified “warning” letter from the Department of Health and Human Services to Dr. Frederick Coulston, TCF’s CEO and Chairman of the Board, concludes that the conditions at his facility “are serious violations of the GLP regulations,” and warns that the results of future studies at TCF would be considered “seriously flawed” if these deficiencies are not corrected.