IA #57-16 - 6/13/01, IMPORT ALERT #57-16, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF PURIFIED UROKINASE POWDER FROM CHINA OR OTHER FOREIGN SOURCES"
TYPE OF ALERT: Detention Without Physical Examination
NOTE: This import alert represents the Agency's current
guidance to FDA field personnel regarding the manufacturer
(s) and/or product(s) at issue. It does not create or
confer any rights for or on any person, and does not operate
to bind FDA or the public.
PRODUCT: Urokinase, purified powder
PRODUCT CODE: 57YY-99, 57AY-18
PROBLEM: Misbranded drug
PAF: LBL-Labeling
PAC: 41R800
COUNTRY: See Attachment
MANUFACTURER/
SHIPPER: See Attachment
CHARGE: "The article is subject to refusal of admission pursuant to
section 801(a)(3) in that it appears to be misbranded in
that its labeling lacks adequate directions for use.
[Misbranding, Section 502(f)(1)]."
RECOMMENDING
OFFICE: CBER, Office of Compliance and Biologics Quality, Division
of Case Management, HFM-610
REASON FOR ALERT: It has recently come to CBER's attention that some bulk
shipments of unapproved Urokinase purified powder identified
either as a "sample for testing only" or as a "sample"
entered the U.S. where it was repackaged, relabeled, and
sold to a pharmacy. The pharmacy used the material to
manufacture a new drug for human use and distributed the
drug. There are currently no approved foreign sources of
urokinase purified powder.
GUIDANCE: Districts may detain without physical examination Urokinase
from the firms identified on the attachment to this alert.
Surveillance of Urokinase from other unapproved sources is
warranted.
Districts encountering imported, purified Urokinase powder
should contact OCBQ/DCM, Import/Export Staff at (301)827-
6201.
For questions or issues concerning science, science policy,
sample collection, analysis, preparation, or analytical
methodology, contact the Division of Field Science at (301)
827-7605.
PRIORITIZATION
GUIDANCE: N/A
FOI: No purging is required.
KEY WORDS: Urokinase purified powder, Urokinase, biologic
PREPARED BY: Stella Notzon, DIOP, (301) 443-6553
DATE LOADED INTO FIARS: July 13, 2001
ATTACHMENT TO IMPORT ALERT #57-16
FIRMS RECOMMENDED FOR DWPE, 6/13/01
Guangdong Techpool/Biochemical Pharmaceutical Co. Ltd. (GTBP)
12 Jianzhong Road
Tianhe Hightech IND/L PK
Guangzhou, China 510630
FEI # 3002548605
Luye Pharmaceutical Co., Ltd.
[aka Shandong Luye Pharmaceutical Group Co., Ltd. or Yantai Luye
Pharmaceutical Co. Ltd]
No. 9 Baoyuan Rd., Yantai High-Tech Industrial Development Zone
(APEC Industrial Park)
Laishan District
Yantai, Shandong, China 264003
FEI # 3003153176
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