Impro Products, Inc. Waukon, IA (8/18). Inspected 8/26-27/03 and 3/23/04. Unapproved new animal drug: Adulterated: Labeling for several Whey Blend products include 13 microbiologic taxonomy terms implying that they have an antimicrobial effect. This implication is further supported by a labeling statement that the whey is “processed from milk produced by dairy cows exposed to a known environment.” The products are also packaged in parenteral type bottles with a rubber stopper and metal crimp top, etc. (Whey Blend products); FDCA 501(a)(5) (KAN 2004-15)
http://www.fda.gov/foi/warning_letters/g4930d.pdf
Medical Industries America, Inc. Adel, IA (8/23). Inspected 6/16-7/6/04. GMP deviations, adulterated: The generators used in the manufacturing of Aeroneb Go have at least two identified component defects that can cause the nebulizer to not start or result in a low flow. The firm continues to use this part in the manufacture of the nebulizer, despite knowledge of the modifications necessary to correct the problems with this component. (Aeroneb Go Micropump Nebulizers); FDCA 501(h), 21CFR 820.100(a) (KAN 2004-16)
http://www.fda.gov/foi/warning_letters/g4928d.pdf
Terumo Cardiovascular Corp. Ann Arbor, MI (8/31). Inspected 5/10-18/04. QSR deviations, adulterated: Company failed to establish and maintain an adequate organizational structure to ensure that its medical devices are designed and produced in accordance with the requirements of 21 CFR 820.20. Terumo failed to establish and maintain procedures for quality audits to assure that the quality system is in compliance with the requirements and failure to conduct quality audits at sufficient regular intervals. The company also failed to verify or validate corrective and preventive actions to ensure that such actions are effective and do not adversely affect the finished device. It did not maintain and follow its complaint handling system to address all the requirements of 21CFR 820.198, etc. (cardiovascular bypass products); FDCA 501(h), 21CFR 820.20, 820.22, 820.100(a), 820.198 (2004-DT-06)
