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.
Allergan, Inc. Irvine, CA (5/25). Reviewed a professional journal ad for Acular LS submitted by the firm. Misbranded: The ad is false or misleading because it broadens the indication, presents unsubstantiated superiority claims, and omits important risk information. The ad suggests that Acular LS is effective in a broader range of patients and conditions than has been demonstrated by substantial evidence or substantial clinical experience. The ad suggests that Acular LS is effective for an entirely new use in data that are presented to show a favorable result in a study of patients undergoing phacoemulsification. The data include a bar graph comparing the means of aqueous concentrations of Acular LS with the prodrug and active molecules of Nevanac — amfenac and nepafenac. Acular LS is depicted as having a greater mean aqueous concentration than nepafenac and amfenac. Also the headline for the journal ad states: “Acular LS: Oustanding Ocular Penetration.” FDA says the emphasis on “mean aqueous concentrations” and “penetration achieved” with Acular LS suggests that it is effective for use in patients undergoing phacoemulsification, which is not supported by substantial evidence or clinical experience, etc. (Acular LS); FDCA 352(n), 321(n) (No Code)
http://www.fda.gov/foi/warning_letters/s6376c.pdf
Metasurg Houston, TX (5/14). Inspected 2/26-3/20. QSR deviations, adulterated: At the time of inspection the firm failed to follow its Design Control SOP in that it did not establish adequate design risk analysis techniques, methods or procedures, or perform and document design risk analyses at any stage in the design process of the T6 Titanium Internal Fixation System in order to define, document, and mitigate all possible risks associated with the specifically designed bone screws and surgical instruments. The firm’s design validation and records did not include adequate test procedures using recognized standard test methods or other methods to measure the performance and structural integrity of the bone screws. The firm made several post-production design changes to the (purged) bone screw series without conducting and documenting adequate testing to ensure conformance to approved specifications, etc. (T6 Titanium Internal Fixation System Implant); FDCA 501(h), 21CFR 820.30(c)&(d)&(e)&(g)&(i)&(j), 820.80(b), 820.50(a)&(b), 820.184, 820.198 (2007-DAL-WL-16)
http://www.fda.gov/foi/warning_letters/s6374c.pdf
