Today FDA posted its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following each letter.
Arkray Inc. Kyoto, Japan (6/15). Inspected firm in Ritto-Shi, Shiga-ken, Japan 2/10-13. QSR deviations, adulterated: The firm did not follow its (purged) in that when a non-conformity occurred and it was deemed to be "OK," the individual authorizing the use of the product, did not document the action by signing off on the action. Also Arkray failed to follow the SOP and discarded the non-conforming products along with the non-conformance slips. Its complaint handling procedure does not require complaints to be evaluated for MDR reporting. The firm’s CAPA procedure does not include a requirement for data analysis. The only data analysis is performed by Bayer Healthcare and Arkray Factory USA, its sister company. No data analysis is performed by Arkray (Kusatsu) for MDRs and non-conformance reports, etc. (glucose test systems); FDCA 501(h), 21 CFR 820.198(a), 820.100(a), 820.90 (No code)
Bazaar of India, Inc.
Feins, Neil R. MD Children's Hospital Boston, Boston, MA (5/20). Inspected 2/4, 10 and 17. Violations: There was no documentation that a parent signed and dated an informed consent form (ICF) for one subject. The investigator also failed to use the approved ICF for the subjects enrolled in the study. He enrolled subjects who did not meet the eligibility criteria set forth in the investigational plan, etc. (device study); 21 CFR 50.20, 50.25, 50.27, and 50.55(f), 812.100 and 812.110(b), 812.140(a) (No code)
Staten Island University Hospital IRB, Staten Island, NY (6/29). Inspected 3/16-4/3. IRB violations: Previous versions and the most recent informed consent forms dated "approved 10/8/08 to 10/7/09" did not contain the following elements: statements notifying subjects of the purposes of the research and the expected duration of the subject's participation; a description of the procedures to be followed; and a description of any benefits to the subjects or to others which may reasonably be expected from the research. The IRB also failed to ensure that the IRB reviews proposed research at convened meetings at which a majority of the members are present, including at least one member whose primary concerns are in nonscientific areas, etc. (IRB); 21 CFR 50.25(a) and 21 CFR 56.109(b), 56.108(a), 56.115(a)(4) and (a)(5) (No code)
Karl Storz GmbH & Co.
Thomas K. Jones, MD Seattle, WA (7/1). Inspected 3/6-3/19. Violations: The investigator failed to ensure that informed consent was obtained in accordance with 21 CFR Part 50, failed to conduct the investigation in accordance with the investigational plan and conditions of approval imposed by the IRB. Also the device receipt and disposition records were inadequately maintained. Section 8.1 of the protocol states that progress reports are to be sent to the sponsor and the IRB, but there was no documentation or evidence in the study records to show that the annual progress reports were submitted to the sponsor, etc. (device study); 21 CFR 50.20, 50.27(a), 812.100 and 812.110(b), 812.150(a)(3), 812.140(a)(2) (No code)
