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.
Melanocorp, Inc. Hendersonville, TN (8/30). Unapproved new drug. Claims on www.melanocorp.com such as “Hormone shots help tanning, cut sun damage: study" and "Drug can induce tanning" indicate the product is intended for use to prevent, treat, or cure disease conditions, which make it an unapproved new drug, etc. (Melanotan II); FDCA 505(a) (2007-NOL-15) http://www.fda.gov/foi/warning_letters/s6491c.pdf
Ochsner Clinic Foundation New Orleans, LA (8/29). Inspected 6/5,7 and 11. Deviations from the regulations for human cells, tissues, and cellular and tissue-based products: Clinic failed to test a specimen from an anonymous or directed donor of reproductive cells or tissue to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents of the genitourinary tract, including Chlamydia trachomatis and Neisseria gonorrhea. No documentation was found during the review of six anonymous oocyte donor files from 2006 and 2007 to substantiate a responsible person, either from the firm or from the oocyte donor organizations, had determined the donors to be eligible for donation. Clinic failed to collect a donor specimen for testing for relevant communicable diseases within 30 days before oocyte recovery or up to seven days after recovery, etc. (human cells, tissues, and cellular and tissue-based products); 21 CFR 1271.85(c), 1271.50(a), 1271.75(a), 1271.3(n), 1271.55(d)(1) &(3), 1271.47(a) & (b) (2007-NOL-14)
Wheaton Beauty Supply Wheaton, MD (8/27). Inspected 5/30. Misbranded: Firm sells plano lenses directly to consumers without requiring any evidence of proper fitting or other eye care professional involvement. FDA has determined that these lenses are marketed without labeling describing the risks associated with the wearing of such lenses. The lenses are being sold to retail establishments such as flea markets, gas stations, beauty shops, clothing stores, and beauty supply stores without requiring any evidence of proper fitting or other eye care professional involvement. The lenses distributed by your firm have been cleared by FDA for prescription use only and are exempt from the Act’s requirements that they bear adequate directions for use if they are sold with a prescription. (plano lenses); FDCA 502(f)(1) (#07200322)