FDA EIR - AMA Laboratories, Inc. - November 17, 2016

AMA Laboratories, Inc., a clinical testing laboratory for skincare, haircare, cosmetics, and OTC drug products, underwent an FDA inspection from November 16-17, 2016. The inspection, conducted under the framework of Drug Manufacturing Inspections (CPGM 7356.002) and covering Quality and Laboratory Control Systems, aimed to assess compliance. While no significant deficiencies warranted an FDA-483 issuance, the inspection highlighted several areas for attention. In antiperspirant efficacy studies, the temperature and humidity controlled chamber's certification parameters did not fully align with all established study protocols, specifically regarding the high-end temperature range. During broad spectrum testing, initial concerns arose regarding the analytical balance calibration, as the minimum standard weight used did not assure accuracy for the small product samples tested, though a revised calibration report addressed this. Additionally, the reference standard for the spectrometer used in broad spectrum testing had a calibration date over 16 years old, raising questions about its current validity, despite management providing an email suggesting long-term stability. The firm also lacked a dedicated written procedure for handling complaints, relying instead on a general preventive/corrective action process. Despite these observations, the firm's corrective actions addressing previous GMP equipment calibration and qualification concerns from a 2012 inspection were found generally adequate. No official regulatory actions or mandatory rectifications were imposed, as no FDA-483 was issued. The agency emphasized the firm's responsibility to ensure instrument calibration covers the entire operating range and that all calibration records are thoroughly reviewed for intended use.