Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Deston Therapeutics, LLC. Chapel Hill, NC (2/5). Unapproved new drugs, adulterated (Novahistine DH CIII liquid — dihydrocodeine bitartrate 6.5 mg, chlorpheniramine maleate 2 mg, and phenylephrine HCl 4 mg and Aquatab C Tablets — guaifenesin 400 mg; carbetapentane citrate 30 mg; phenylephrine HCl 10 mg); FDCA 505(a), 502(f)(1) (10-ATL-08)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm203037.htm

G3 Medical Asheville, NC (10/13/09) Inspected 8/3-24/09. QSR deviations, adulterated: The firm has not adequately validated the Ethylene Oxide Gas Diffusion Sterilization Process for medical products which are sterilize at the facility. During sterilization load numbers 08276 and 08029, the number of sterilization bags exceeded the number of allowable sterilization bags. The firm did not adequately identify the root cause of positive biological indicator results for several sterilization loads. Incubation temperature for the biological indicators was below the specified incubation time and/or was not recorded for four sterilization loads, etc. (spinal & epidural needles, catheters, wound dressings, drapes, surgical markers, and convenience kits); FDCA 501(h), 21 CFR 820.75(a) &(b), 820.100(b), 820.75(c), 820.184(d), 820.70(a)(1). (10-ATL-01)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm204223.htm

Genetics & IVF Institute IRB (12/23/09). Inspected IRB from 9/24-10/1/09. Deviations: There is no documentation to demonstrate that the IRB conducted continuing review from 11/02 to 2/05 although the study was ongoing and under the oversight of the IRB during that time. The available meeting minutes from 5/00 through 7/09 do not consistently list the members in attendance or include, for particular items being reviewed, the number of members voting for, against or abstaining. At the 5/17/01 and 9/26/02 IRB meetings, a principal investigator and then chairman of the IRB, was present during the review of three studies in which he had a conflicting interest. There is no documentation in the minutes that Dr. Opsahl refrained from voting on the approval of these three studies, etc. (device study); 21 CFR 56.109(f), 56.115(a)(2)&(3)&(5), 56.110(c), 56.107(e), 56.120(b)(1)&(2) (No code)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm203906.htm

Glenmark Generics Inc. Mahwah, NJ (3/16). Unapproved new drugs (nitroglycerin tablets, 0.3 mg, 0.4 mg, and 0.6 mg.); FDCA 505(a), 502(f)(l) (No code)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm204540.htm

ISTA Pharmaceuticals Inc. Irvine, CA (3/10) Reviewed a professional sales aid for Xibrom. (bromfenac ophthalmic solution) 0.09%. Misbranded: DDMAC says the aid is false or misleading because it presents unsubstantiated superiority claims, broadens the indication of Xibrom, overstates its efficacy, omits and minimizes important risk information for the drug, makes misleading patient preference claims, and omits other material facts. Page two of the aid states, “Xibrom: Greater Potency . . .” and “Bromfenac has up to 4x greater inhibition of the COX-2 enzyme.” These claims are followed by a chart of in vitro data comparing the IC50 (concentration of drug necessary for 50% inhibition of the COX-2 enzyme) and relative potency of bromfenac to those of the ocular NSAIDs amfenac, ketorolac, and diclofenac. Bromfenac is shown with the lowest IC50 and highest relative potency of all the agents, implying that bromfenac is the most clinically effective. DDMAC says in vitro data are not a reliable predictor of the level of activity in the anterior chamber of the eye and no clinical significance of this data has been demonstrated, etc. (Xibrom); FDCA 352(a) & 321(n), 21 CFR 202.1(e)(5); (6)(i); (ii) & (vii); (7)(vi) & (viii). (No code)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm204321.htm

Kirk Pharmaceuticals, LLC Fort Lauderdale, FL (2/4). Inspected 6/17-7/2/09. GMP violations, adulterated: The firm has not rejected drug products failing to meet established standards or specifications and any other relevant quality control criteria. It also failed to investigate dissolution failures (between 11/20/08 and 6/19/09) for validation lots of ephedrine HCl 12.5 mg/guaifenesin 200 mg hard gelatin capsules. The firm has not established and documented the accuracy, sensitivity, specificity, and reproducibility of test methods employed, etc. (drug products) FDCA 501(a)(2)(B), 21 CFR 211.165(e)&(f), 211.110(b), 211.22(d), 211.180(e) (FLA-10-12)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202958.htm

Konec, Inc. Tucson, AZ (3/16). Unapproved new drugs (nitroglycerin tablets, 0.3 mg, 0.4 mg, and 0.6 mg); FDCA 505(a), 502(f)(l) (No code)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm204546.htm

Linn, Henry MD New Mexico Veteran’s Administration Health Care System Albuquerque, NM (3/8). Inspected 9/15/08 and 7/1/09. Clinical sponsor violations: The sponsor failed to ensure proper monitoring of the clinical investigations. Linn provided no additional documentation with his response, relying only on the Data Safety Monitoring Board (DSMB) research monitoring plan dated 2/6/07, and DSMB Review dated 9/9/09, collected during the 2009 inspection, to support the assertion that the DSMB provided adequate monitoring to meet his obligations as sponsor. Yet these two documents indicate only that the DSMB was to monitor adverse events, and that as of 9/9/09, it had determined that there had been no new adverse events reported since the last DSMB review. The sponsor also failed to obtain a signed investigator statement, Form FDA 1572, before permitting an investigator to participate in an investigation, etc. (drug study); 21 CFR 312.50, 312.56(a), 312.53(c)(1), 312.55(a), 312.56(c), 312.57(a)&(b)&(c) (10-HFD-45-03-01)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm204453.htm

Tri-Med Laboratories Inc. Somerset, NJ (2/23). Inspected 9/9-25/09. GMP violations, unapproved new drugs, misbranded: The firm’s Quality Control Unit did not reject the API Guaifenesin USP, when it failed to meet established specifications for the potency assay. The firm’s Nonconformance / Discrepancy Investigation Report failed to thoroughly investigate the aerobic plate count failure of a purified water sample. It also failed to follow written procedures describing the receipt, identification, storage, handling, sampling, testing, and approval or rejection of drug components and drug product containers and closures, etc. (finished pharmaceuticals including Guiatex PE Syrup, Pseudo DM GG Syrup, Triall Syrup, etc.); FDCA 501(a)(2)(B), 21 CFR 211.84(e), 211.192, 211.160(b), 211.80(a), 211.67(a) ( (10-NWJ-07)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm204130.htm

www.sharco.tv and http://biologicalmiracle.com (12/9) Unapproved new drug: The product “SHACRO” which is purported to be an “Emulsified Dual Protein Anti-Microbial Peptide” derived from the blood of crocodiles and sharks, is being promoted for conditions that cause it to be a drug. These Web sites also contain personal testimonials that constitute therapeutic claims. (Shacro); FDCA 321(g) (No code)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm203026.htm

Z-Medica, LLC Wallingford, CT (12/909) Inspected 10/26-28/09 and 11/3/09. QSR deviations, adulterated: The firm’s procedure for process validation of its sealing machine lacks documentation of monitoring of periodic burst testing of in process or finished product during periodic manufacturing. The firm also failed to review, evaluate, and investigate a complaint involving the possible failure of a device, labeling or packaging to meet any of its specification. The firm failed to conduct management reviews at defined intervals, etc. (haemostatic agents including QuikClot Combat Gauze); FDCA 501(h), 21 CFR 820.75 (a) & (b), 820.198 (c), 820.20 (c) (NWE-09-10W)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm203960.htm