Recently added articles from Warning Letter Bulletin:
Legacy Pharmaceuticals International.(HUMAN DRUGS)
Jun 01, 2008 ... Birsfelden, Switzerland, May 7 (San Juan District) An FDA inspection conducted Sept. 10-28 at Legacy's facility in Puerto Rico revealed that the manufacture, processing, packing or holding of the human drug product Efudex Topical Cream 5% deviated from GMP, rendering the drug ...
Safer Sleep.(MEDICAL DEVICES)
Jun 01, 2008 ... Nashville, TN, May 27 (New Orleans District) FDA cited Safer Sleep for GMP violations resulting in the adulteration of the device, following an inspection Nov. 13, 16 and 20. The company failed to establish and maintain procedures for validating the device design, ...
Steris Corporation.(MEDICAL DEVICES)
Jun 01, 2008 ... Mentor, OH, May 15 (Cincinnati District) Leading medical device sterilizer firm Steris received a warning letter concerning a variety of GMP and pre-market approval violations, including making changes to software without 510(k)s. Following a review of company records ...
Novartis Pharmaceuticals.(DDMAC)
Jun 01, 2008 ... East Hanover, NJ, May 1 (DDMAC) FDA deemed a Partial Seizure Lenticular Magnet for Trileptal (oxcarbazepine) Tablets and Oral Suspension violative "because it omits the full indication for Trileptal and omits information about the risks associated with its use" and thus ...
Shire Development.(DDMAC)
Jun 01, 2008 ... Wayne, PA, May 1 (DDMAC) The Division of Drug Marketing, Advertising, and Communications (DDMAC) reviewed a Notebook (FOS1598) and a Medical Exam Light Case (FOS1597) submitted by Shire Development for Fosrenol (lanthanum carbonate) and determined the items violative "because ...
ZymoGenetics.(BLOOD & BIOLOGICS)
Jun 01, 2008 ... Seattle, WA, April 25 (CBER) The Advertising and Promotional Labeling Branch (APLB) of FDA's Center for Biologics reviewed information on the website http://www.zymogenetics.com including a press release for Recothrom (Thrombin, Topical (Recombinant)) and concluded that this ...
Advanced Orthopaedics of South Florida.(BIMO/NIDPOE/ORI/OHRP)
Jun 01, 2008 ... Lake Worth, FL, May 6 (CDRH) An FDA inspection conducted Dec. 13-21 found "serious violations" of regulations regarding IDES, protection of human subjects and other regulations, according to FDA's warning letter. The agency cited the company for failing to ensure ...
Carondelet Health Network.(BIMO/NIDPOE/ORI/OHRP)
Jun 01, 2008 ... Tucson, AZ, May 13 (OHRP) According to a Dec. 19 letter, OHRP determined that Carondelet Health Network (CHN) does not have written IRB procedures that adequately describe the following activities: * The procedures the IRB will follow for reporting its findings and ...
Arthur Ericsson, M.D.(BIMO/NIDPOE/ORI/OHRP)(Clinical report)
Jun 01, 2008 ... Houston, TX, March 31 (CDER) Between March 22 and April 18, FDA conducted an investigation and met with Ericsson to review the conduct of a clinical investigation to evaluate an investigational drug for the therapy of autoimmune/inflammatory conditions involving the nervous ...
George Washington University.(BIMO/NIDPOE/ORI/OHRP)
Jun 01, 2008 ... Washington, D. C., May 6 (OHRP) At the request of OHRP, George Washington University (GWU) evaluated allegations of noncompliance with regulations for the protection of human research subjects. The complainant alleged that the university's institutional review board ...
J. David Gladstone Institutes.(BIMO/NIDPOE/ORI/OHRP)
Jun 01, 2008 ... San Francisco, CA, May 19 (OHRP) OHRP determined that the University of California, San Francisco (UCSF) institutional review board (IRB) approved an informed consent document for the above-referenced research that did not include an ex planation of whom to contact for answers ...
Lehigh Valley Hospital & Health Network.(BIMO/NIDPOE/ORI/OHRP)
Jun 01, 2008 ... Allentown, PA, May 1 (OHRP) It was alleged that the Lehigh Valley Hospital (LVH) IRB did not review and approve protocol changes and enrolled a complainant's husband into a research project even though he was ineligible due to treatment with the anti-arrhythmic medication ...
Saint John's Health System.(BIMO/NIDPOE/ORI/OHRP)
Jun 01, 2008 ... Anderson, IN, April 28 (OHRP) In a September 14 letter OHRP found that the suspension of institutional review board (IRB) approval for Radiation Therapy Oncology Group (RTOG) 0615, which was documented in the June 13 IRB meeting minutes, was not reported to appropriate ...
University of Arizona.(BIMO/NIDPOE/ORI/OHRP)
Jun 01, 2008 ... Tucson, AZ, May 2 (OHRP) OHRP determined in June 2007 that the principal investigator for a research study at the University of Arizona initiated changes to the research without IRB review and approval, and as a result, failed to protect the privacy of subjects and to maintain ...
University of Connecticut Health Center.(BIMO/NIDPOE/ORI/OHRP)
Jun 01, 2008 ... Farmington, CT, April 28 (OHRP) OHRP determined that in the course of three research projects concerning medications for alcoholism, investigator Henry Kranzler, M.D., conducted non-exempt human subjects research without prior IRB review and approval when he created a ...
Changzhou SPL.(HUMAN DRUGS)
May 01, 2008 ... Changzhou, China, April 21 (CDER). The Chinese company that triggered a major international crisis regarding the safety of heparin and exposed FDA and drug manufacturers to heightened over sight from Congress failed to adequately address issues cited in an agency inspection, ...
Gemtronics.(HUMAN DRUGS)
May 01, 2008 ... Franklin, NC, April 17 (Atlanta) FDA notified Gemtronics that after a review of their websites the agency determined that the products Agaricus dried Grade A, Agaricus dried Grade A Powder, Agaricus Capsules, Agaricus sweet Extract, Agaricus strong Extract, RF 1000 Extract, APM ...
Connecticut Educational Services.(MEDICAL DEVICES)
May 01, 2008 ... Middletown, CT Warrensville Heights, OH, April 24 (CDRH) FDA inspectors concluded that both firms, which market the Good Vibrations device, were out of compliance with GMP/Quality System (GMP/QS) rules and that their devices are adulterated and misbranded because the firms do ...
Heartsine Technologies.(MEDICAL DEVICES)
May 01, 2008 ... Belfast, Northern Ireland, U.K., April 18 (CDRH). The Samaritan Automatic External Defibrillator (Samaritan AED) and the Samaritan Public Access Defibrillator (Samaritan PAD) devices manufactured by Heartsine are adulterated, FDA concluded after its inspection Nov. 26-29, due to ...
National Biological Corporation.(MEDICAL DEVICES)
May 01, 2008 ... Beachwood, OH, April 23 (Cincinnati) The UV phototherapy systems for treating dermatological disorders manufactured by National Biological Corporation are adulterated due to lack of conformity with device GMPs, FDA concluded after an inspection conducted Jan. 14-Feb. 27. ...