FDA WARNING_LETTER - Jabones Pardo S.A. - March 14, 2013

The FDA inspected Jabones Pardo S.A.'s pharmaceutical manufacturing facility in Fuenlabrada, Madrid, Spain, from March 11-14, 2013, identifying significant violations of current good manufacturing practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering drug products adulterated. The firm also failed to meet drug registration and listing obligations under Section 510(i)(1), (i)(2), and (j) of the Act. Key CGMP violations included the failure to perform appropriate laboratory testing for identity and strength of active ingredients prior to drug product release, inadequate testing of components and validation of supplier analyses, lack of an adequate stability testing program to determine expiration dates, the quality control unit's failure to review and approve production records before batch release, and insufficient calibration/validation of equipment, including computer software. Additionally, Le?dermis Skin Solutions Anti-Acne Medicated Cream was deemed an unapproved new drug (Section 505(a)) due to an unpermitted combination of active ingredients. Le?dermis, Caro Light Skin Lightening Lotion, and Topiclear Skin Lightening Lotion were all misbranded (Section 502(c)) due to the absence of required expiration dates and insufficient stability data. A labeling error for Octyl Methoxycinnamate in the Drug Facts Panel was also noted. The FDA expressed concern over the quality unit's responsibilities and recommended a qualified consultant. Jabones Pardo S.A. must provide a written response within fifteen working days detailing corrective actions. Failure to comply may result in FDA withholding new application approvals and refusing product admission into the U.S. under Section 801(a)(3) of the Act.