Apothecary Products, Inc. – FDA Warning Letter, Sep 30, 2009

During inspections from April 28 - June 1, 2009, and September 25 - 30, 2009, FDA determined Apothecary Products, Inc. manufactures contact lens cases (e.g., Econo-Mate, Soft Grip, Deluxe, Color-Mate Deluxe, Travel-Mate) which are medical devices. These devices are adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE). The devices are also misbranded under section 502(o) for failure to submit a 510(k) premarket notification.

The firm's July 16, 2009, response to the FDA-483 observations (CAPA numbers 00106, 00105, 00104, 00103, 00102) was deemed incomplete. FDA requires submission of specific procedures and supporting documentation for corrective actions, including: procedure (b)(4) Incident Review (CAPA 00106), (b)(4) MDR Reporting working instruction (CAPA 00105), updated procedure (b)(4) and corrections to the complaint database (CAPAs 00104, 00103), and