Lake Charles Memorial Hospital Lake Charles, LA (5/27). Inspected 2/4-6/03. IRB violations: Failure to conduct continuing reviews of approved research, improper use of expedited review, failure to maintain records of IRB deliberations, and failure to establish written standard operating procedures governing reporting of unanticipated problems, etc. (device studies); 21CFR 56.109, 56.110(b), 56.115(a), 56.108(b)(1) (No Code) http://www.fda.gov/foi/warning_letters/g4048d.pdf
Southwest Instrument Company Charleston, AK (5/14). Inspected Wilson Urology Associates, Van Buren, AK (5/14). QSR deviations, adulterated, misbranded: Firm has not established a quality policy, quality plan, device master records, device history records, and complaint files and procedures for quality and specification requirements that must be met by contractors, acceptance, and rejection of finished devices, packaging and labeling activities, and complaint handling. Southwest Instrument also did not establish and maintain procedures for acceptance of incoming product. For example, the inspection documented that the contractor wrapped the devices in newspaper and sent them to Southwest for inspection. Southwest visually inspected the devices for defects, but had not established any acceptance criteria or maintained records of device acceptance or rejection, etc. (Rosello Cavernotome Sets, Brook Cavernosal Dilator Sets, Mohamed Closing Tools); FDCA 501(h), 502(o), 21CFR 820.20, 820.50(a), 820.80(b), 820.181, 820.184, 820.198(a) (2003-DAL-WL-11)
http://www.fda.gov/foi/warning_letters/g4044d.pdf
Warner Chilcott, Inc. Rockaway, NJ (3/18). Inspected 10/7/02-10/18/02. Violations: Failure to review and submit to the FDA adverse drug experience reports as required by 21CFR 314.80(b)&(c) in that there were twenty-one telephone log entries to Warner Chilcott describing adverse drug events that were not reviewed or reported to FDA. There were also nine telephone log entry reports that were inadequate in that they were illegible or lacked sufficient text to identify the nature of the call in order to determine if a reportable adverse event had occurred. Company failed to submit to FDA serious and unexpected adverse drug experience reports within 15 calendar days of initial receipt of information, including reports on Duricef, Pyridium, and Doryx, etc. (drug products); FDCA 301(e), 505(k), 21CFR 314.80 (03-NWJ-04)
