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 ...