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MEI-CHA INTERNATIONAL, INC. <br /> To Whom It May Concern: <br /> Re:Mule&Accessories SkwHilzadon Mead Inquwy <br /> All of our needles, casings and tips are Gamma Sterilized. . All of our products(both box and individual <br /> item)are stamped with a LOT CODE and EXPIRATION DATE and copies of Sterilization Reports are kept <br /> on file both at our factory in Taiwan and our office here in Tustin, USA. <br /> Our Taiwan factory uses China Biotech Corporation(CBC)for their sterilization needs which was the first <br /> commercial gamma sterilization facility in Taiwan-a joint venture with Sterigenics International, Inc. <br /> (USA)and licensed by the Atomic Energy Council (AEC). CBC's gamma sterilization processes are in Full <br /> Compliance with the GMP(Good Manufacturing Practice) standards and FDA regulations. They hold <br /> such proper factory certifications of: ISO9001, IS013485 (with EN/I5011137), IS014001 and <br /> OHSAS18001. China Biotech Corporation provides radiation sterilization processing service to <br /> healthcare, laboratory, pharmaceutical,food, packaging, cosmetics and other related industries. <br /> GAMMA STERILIZATION <br /> Gamma rays are very penetrating and are commonly used for sterilization of disposable medical equipment, such as <br /> syringes,needles,cannulas and IV sets. Gamma radiation requires bulky shielding for the safety of the operators; <br /> they also require storage of a radioisotope(usually Cobalt-60),which continuously emits gamma rays.(Regulatory <br /> Standard-ISO 11137) <br /> If the Health Department has any other questions, please have them contact us directly, as it is very <br /> important they receive all of the correct information when it comes to the Permanent Cosmetics <br /> industry,which Mei-Cha has been a leader in the industry for more than 30 years. <br /> Jasow mald 'strd <br /> Vice President <br /> Mei-Cha International Inc. <br /> Tel: (714) 566-0066 <br /> Fax: (714) 566-0206 <br /> 15441 RED HILL AVENUE, SUITE E,TUSTIN,CA 92780-7304 U.S.A. <br /> TEL: 714/566-0066 FAX: 714/566-0206 WEBSITE:WWW.MEI-CHA.COM <br />