Better Way Kids Cranston, RI (8/9). Inspected 5/28, 6/6. Unapproved new drug, misbranded: A promotional brochure entitled “Calm Focus” states that the product, “…helps children and adults with attention deficit hyperactivity disorder. The products also fails to bear adequate directions for use, etc. (Calm Focus); FDCA 505, 502(f)(1), 502(a) (NWE-26-02W) http://www.fda.gov/foi/warning_letters/g3437d.pdf
GHMedical.com Hallandale, FL (6/29). Unapproved new drug, misbranded: The Web site www.ghmedical.com is promoting Saizen as part of an anti-aging treatment regimen. The product’s new drug application with FDA was approved for one indicated only, for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone. (Saizen); FDCA 355(a), 352(f)(1), 333(f), 333(e) (FLA-02-54)
http://www.fda.gov/foi/warning_letters/g3437d.pdf
Medpointe Healthcare, Inc. (7/22). Inspected 5/20-6/6. GMP deviations, adulterated: Firm failed to thoroughly investigate and implement effective corrective actions for the presence of black specks, containing metal particles, which were visibly present on tablet surfaces of Soma 350 tablets. There also was no documented health hazard evaluation to determine the risk associated with the potential metal contamination. Rejected tablets were identified for three lots after an initial pass through a metal checker and visual screening inspection, but after a second metal detector screening yielded an even higher number of rejected tablets, there was no follow-up investigation to document the rationale for continued screening, etc. (Soma 350 carispordol tablets); FDCA 501(a)(2)(B), 21CFR 211.192, 211.110, 211.65(b), 211.67 (02-NWJ-26)
http://www.fda.gov/foi/warning_letters/g3435d.pdf
NatureMost of New England Inc. Middletown, CT (8/9). Inspected firm dba NatureMost Laboratories, Inc. and Trigo Laboratories, Inc. Unapproved new drug, misbranded: A promotional brochure entitled “Trigo Laboratories Calm Focus” states that it “ …helps children with attention deficit hyperactivity disorder. Claims that the product is a natural approach to help ADHD are false and misleading in that they are not supported by sufficient scientific studies and therefore cause the product to be misbranded, etc. (Calm Focus); FDCA 505, 502(f)(1), 502(a) (NWE-27-02W)
http://www.fda.gov/foi/warning_letters/g3444d.pdf
Wallace O’Farrell, Inc. Puyallup, WA (8/7). Inspected 6/21,24. GMP deviations, adulterated: There were no written procedures for production and process control designed to assure that the drug products have the identity, strength, quality and purity they purport or are represented to possess. There were no criteria for the release of the firm’s drug product. The gel formulating records for two lots did not indicate they were reviewed and approved by the quality control unit. There was no written methodology for sampling and testing the finished product for microbial contamination and there was no thermometer for the incubator used for microbial testing, etc. (Slippery Stuff); FDCA 501(a)(2)(B), 351(a)(2)(B), 21 CFR 211.100(a), 211.165(d), 211.192, 211.160(b), 211.67(c), 211.130, 211.46(a), 211.166(a), 211.25 (SEA 02-57)
