IA #80-02, 8/14/98, IMPORT ALERT #80-02 "Detention Without Physical Examination of Clinical Mercury-In-Glass Thermometers For Failure to Meet Accuracy Requirements", Attachment - 7/15/03 (NOTE: This import alert represents the Agency's current guidance to FDA field personnel regarding clinical mercury-in-glass thermometers offered for import. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public.) TYPE OF ALERT : Detention Without Physical Examination PRODUCT : Clinical Mercury-In-Glass Thermometers PRODUCT CODE : 80FLK PROBLEM : Substandard, does not meet ASTM E667 or related specifications. [OASIS Charge Code = DV QUALITY - Adulteration] PAF (Problem Area Flag) : PER (Performance) PAC FOR COLLECTION : 82008 COUNTRY : (See Attachment) MANUFACTURER and FEI : (See Attachment) CHARGE : "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that its quality falls below that which it purports or is represented to possess [adulterated, 21 U.S.C. 501(c)] RECOMMENDING OFFICE : FLA-DO/MIA-RP (HFR-SE2577)/Division of Import Operations & Policy, HFC-170 REASON FOR ALERT : Florida district, Miami resident post, sampled a shipment of mercury-in- glass thermometers. The Winchester Engineering and Analytical Center found that one (1) thermometer out of 24 failed to meet accuracy requirements at two (2) test points and 8 out of 24 thermometers failed to meet accuracy requirements at one (1) test point. The sample was not consistent with the accuracy guidelines found in CPG 335.800. GUIDANCE : Districts may detain, without physical sampling and analysis, entries of mercury-in-glass thermometers from firms in the attachment to this alert. For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 443-3320 or 3007. FOI : No purging is required. PREPARED BY : Jack Geltman, SDWG, DIOP, (301)443-6553 DATE LOADED INTO FIARS: : August 14, 1998 ATTACHMENT TO IMPORT ALERT #80-02 - 7/15/03 LIST OF MANUFACTURERS/SHIPPERS ON DETENTION WITHOUT PHYSICAL EXAMINATION CHINA (CN) FIRM NAME/ADDRESS PRODUCT China Shenyang Medicines Clinical Mercury Thermometers and Health Products 80FLK No. 35 the Touth Business Agency Dept. 7/15/03 Suite #8 Shenyang, China FEI #1000176020