FDA WARNING_LETTER - Proportional Technologies, Inc - August 03, 2010

During a July 15 to August 3, 2010 inspection, the FDA identified significant deviations at Proportional Technologies, Inc.'s facility in Houston, Texas, regarding Positron Emission Tomography (PET) compounding standards and United States Pharmacopeia (USP) monographs. These violations render their PET radiopharmaceutical adulterated under section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act.

Specific violations include: 1. Failure to verify the sterilization process of assembly components and periodically verify sterilizer performance, specifically for the microgenerator and product contact tubing. A color indicator was deemed insufficient for sterilization assurance. 2. Failure to demonstrate sterility and endotoxin-free status of PET radiopharmaceuticals for parenteral administration. This includes the absence of suitability testing in SOP SP06-004A for "Sterility Testing of Generator Eluant" and lack of growth promotion testing for incoming media used in sterility testing. 3. Failure to conduct finished product assembly in an aseptic hood with an air cleanliness rating of (b)(4). This involved using non-sterile cleaning agents (e.g., (b)(4) not filter-sterilized) and lacking environmental monitoring for viable and nonviable particulates. Additionally, there was no evidence of aseptic hood certification to (b)(4) conditions since March 2008.

The FDA requires prompt corrective action within fifteen working days, including a