Case Western Reserve University Cleveland, OH (4/16). Inspected 10/23-12/9/03. GLP deviations: University failed to provide adequate testing facility management in that the management failed to recognize that there were studies conducted at their institution subject to the GLP regulations including studies conducted under (purged) submitted by the University as the sponsor. Management failed to designate study directors with appropriate education, training, and experience to oversee GLP studies and carry out the required responsibilities of a study director. Management also failed to carry out additional responsibilities required under GLP regulations including: designating a quality assurance unit, etc. (laboratory); 21CFR 58.31(a)(c)(f), 58.33, 58.35, 58.63(a), 58.190 (No Code)http://www.fda.gov/foi/warning_letters/g4630d.pdf
Diomedics, Inc. North Melrose, FL (3/29). Inspected 6/25 and 10/27-28/03. Adulterated, misbranded: Company does not have marketing clearance to promote and distribute the Pain-X-2000 as being effective for wound management, skin conditions, soft tissue injuries, joint conditions, fracture, chronic pain, head aches, and activation of acupuncture points, as listed in Diomedics’ Internet promotions. Firm failed to document that the design of its devices followed the approved plan and that the design control requirements are maintained in the design history file. Firm also lacks complete training records for all employees as required, etc. (infrared therapy device); FDCA 501(f)(1)(B), 501(h), 502(a), 502(o), 21CFR 807.81(a)(3)(ii), 820.30(b)(j), 820.30(a)(g), 820.50, 820.25(b) (FLA-04-25)
http://www.fda.gov/foi/warning_letters/g4634d.pdf
KBD, Inc. Erlanger, KY (4/16). Inspected 3/9-12/04. QSR deviations, adulterated: A management representative was not appointed to replace one who left 5/03 to ensure that the quality system requirements are effectively maintained. Two out of three employees questioned did not know the company’s quality policy. The most recent quality audit was performed in 1997. Complete complaint files were not maintained in that the complaint procedure does not address reviewing communications about parts not working properly. There were no device history records covering particular phototherapy lamps and sunlamps manufactured by the firm, etc. (Class III phototherapy lamps); FDCA 501(h), 21CFR 820.20, 820.20(b)(3), 820.20(a), 820.20(b)(2), 820.22, 820.25(b), 820.100, 820.198(a)(3), 820.30, 820.90(b)(1), 820.72(a), 820.181(b), 820.184, 820.80(e), 820.60, 820.160(b), 820.40(a) (CIN-04-21336)
http://www.fda.gov/foi/warning_letters/g4640d.pdf
Janssen Pharmaceutica Titusville, NJ (4/19). Reviewed a “Dear Healthcare Provider” letter for Risperdal: FDA says the letter is false and misleading because it fails to disclose the addition of information relating to hyperglycemia and diabetes mellitus to the approved product labeling, minimizes the risk of hyperglycemia-related adverse events, which in extreme cases is associated with serious adverse events, and fails to recommend regular glucose control monitoring to identify diabetes mellitus as soon as possible. The letter also misleadingly claims that Risperdal is safer than other diabetes mellitus as soon as possible, etc. (Risperdal letter); FDCA 502(a), 201(n), 21CFR 314.81(b)(3)(i) (No Code)http://www.fda.gov/foi/warning_letters/g4628d.pdf
Sandoz GmbH Kundl, Austria (3/29). Inspected 11/3-10/03. Veterinary drug manufacturing GMP deviations, adulterated: Firm failed to develop control systems for its operation as are necessary to prevent contamination of the aseptic processing. It also lacked appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile. During the inspection a company representative told the FDA investigator that the company is evaluating the possibility that microorganisms may be occluded under an oily residue inside the lines and the media fill may not be effective in recovering microorganisms. The agency says this shows an apparent lack of confidence in the methodology’s ability to detect these microorganisms. (veterinary pharmaceutical products); FDCA 501(a)(2)(B), 21CFR 211.42(c)(10)(iv), 211.113(b) (No Code)
