citation_inspection: 552

The registrant uses Freunds complete adjuvant followed by Freunds incomplete adjuvant for antibody production. The adjuvants are injected SQ (and ID) into the rabbits on the right side of their body. Freunds adjuvants (complete & incomplete) are known to produce abscesses &/or granulomas at the site of injections. A random sampling of approx 25 injected rabbits were selected and felt for any SQ hard or soft swellings, abscesses, lumps &/or nodules. Rabbits # 32972, 3205, 331138, 31923, 32770, 3773, 32700 32470, 31510 & 33080 had these types of swellings, & lumps ranging from pea size to grape size (one of the rabbits had a quarter size lump). The exact etiology of these lumps could not be determined during the inspection and will need further veterinary examinations. There was no redness, ulceration, hair loss, or other skin abnormalities on the skin surface in the areas of the lumps/swellings. The registrant has an SOP for the treatment of abscesses & granulomas, but these rabbits did not appear to have the treatment outlined in the SOPs since these lumps have not definitively been diagnosed as abscesses. The sites for the injections of adjuvants are not shaved & the skin is not aseptically prepared prior to the injections. There was no records to demonstrate when & the frequency of follow-up observations/palpations after the injections are being performed to determine if there are any subsequent swelling that might have formed after the injections and to determine if they are treatable or preventable. A research facility shall employ the use of appropriate methods to prevent, control, diagnose, and treat injuries. Have your veterinarian examine these types of SQ lumps/abscesses observed & treat accordingly. Discuss with your veterinarian about aseptically preparing the injection sites to prevent (or reduce these lumps/swellings) &/or subsequent treatments should these swellings/abscesses/lumps occur in the future. Establish & document a routine for checking the animals post treatment and record care accordingly. Have your veterinarian examine these (as well as others) to determine the etiology and treatments if warranted. Correct by October 1, 2016 This inspection and exit interview were conducted with the Institional Official.