Cayman Chemical Company – FDA Warning Letter, May 18, 2009

An FDA inspection conducted between May 12 and 18, 2009, reviewed Cayman Chemical Company's conduct as both sponsor and investigator of clinical investigations involving prostaglandin-containing investigational drugs Compound 1, Compound 2, and Compound 3. The FDA determined that the product, intended for eyelash growth, is regulated as a drug. The inspection revealed significant non-adherence to statutory requirements and FDA regulations governing clinical investigations and human subject protection, specifically 21 CFR parts 50, 56, and 312. Key violations included administering investigational new drugs without an Investigational New Drug (IND) in effect [21 CFR 312.40], charging subjects for investigational drugs without prior FDA authorization [21 CFR 312.8(a)(3)], and failing to maintain adequate records of investigational drug disposition as a sponsor [21 CFR 312.57(a)]. As an investigator, the company failed to obtain legally effective informed consent from subjects [21 CFR 312.60], did not ensure IRB review and approval for the clinical study [21 CFR 312.66], and failed to maintain adequate records of drug disposition, including dates, quantity, and subject use [21 CFR 312.62(a)]. The company's response to the FDA Form 483 was acknowledged but deemed insufficient for not detailing how adherence to regulations would be ensured. The FDA requires a written response within fifteen working days outlining corrective actions to prevent future violations, warning that failure to respond adequately may result in regulatory action.