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
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