Creinin, Mitchell D. Magee’s Women’s Hospital Pittsburgh, PA (6/12). Inspected 1/3-16/02. Clinical investigator violations: The informed consent document signed by male subjects in the study does not identify foreseeable risks of discomfort and irritation to the (purged) and does not describe other risks as stated in the sponsor’s model consent form. Investigator failed to conduct the study in accordance with the investigational plan in that there were no adverse experience forms completed for device-related problems experienced by the male partners of several female subjects despite requirements in the protocol for completing an adverse experience form. Investigator also did not maintain complete records related to each subject’s case history, etc. (study: Lea’s Shield Colposcopy and Microbiological testing); 21CFR 812.100, 50.20, 50.25, 50.27, 812.110(b), 812.140(a) (No Code) http://www.fda.gov/foi/warning_letters/g3332d.pdf
Cut Heal Animal Care Products, Inc. Cedar Hill, TX (5/23). Inspected 1/2, 22/02. Unapproved new animal drugs, adulterated. Representations on the labeling for several products indicate that the products are intended for use in the prevention of disease in animals and that they are intended to affect the structure or function of animals (Cut-Heal Multi+Care Liquid Wound Care, Aerosol Wound Spray, Wound Powder, Ointment Wound Care, Hoof Heal, Pad Heal, derma.calm for horses, Wound & Hot Spot Spray for Dogs, derma.calm for Dogs); FDCA 512(a)(1)(A), 501(a)(5) (2002-DAL-WL-17) http://www.fda.gov/foi/warning_letters/g3320d.pdf
Vintage Pharmaceuticals Huntsville, AL (5/20). Inspected 3/25-29/02. GMP deviations, adulterated: Inspectors revealed inadequate process validation of drug manufacturing, a failure to follow Standard Operating Procedures for change controls and process validation, inadequate stability studies, and inadequate investigations of manufacturing and laboratory deviations, etc. (drug products); FDCA 501(a)(2)(B), 21CFR 211.100, 211.110(a), 211.110(b), 211.166, 211.160(a), 211.165(a) & (f), 211.192 (02-NSV-22) http://www.fda.gov/foi/warning_letters/g3318d.pdf
