IA #57-14, 1/26/06 - IMPORT ALERT #57-14, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF BIOLOGIC DRUGS FROM FIRMS THAT HAVE NOT MET DRUG
GMPs"
TYPE OF ALERT: Detention Without Physical Examination.
(Note: This import alert contains guidance to FDA field personnel
regarding the manufacturer and products 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 : Various biologic drugs (see attachment)
PRODUCT CODE: See attachment
PROBLEM : Failure to meet drug GMPs
(OASIS Charge Code = DRUG GMPS)
PAC : See attachment
PAF : DRT
COUNTRY : See attachment
MANUFACTURER/
SHIPPER : See attachment
MANUFACTURER/
SHIPPER ID #: See attachment
IMPORTERS : See attachment
CHARGE : "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that the methods and controls used in
its manufacture and control of biologic drug products do not
appear to conform to current good manufacturing practices
(GMPs) within the meaning of Section 501(a)(2)(B)."
RECOMMENDING
OFFICE : CBER, Office of Compliance and Biologics Quality Division of
Case Management, HFM-610
REASON FOR
ALERT : FDA will detain affected products if inspection has revealed
that a firm is not operating in conformity with current good
manufacturing practices (GMPs) and if the firm has deviated
from the manufacture of its product(s) in accordance with
the regulations and applicable standards in its U.S.
License. When FDA confirms that the appropriate corrections
have been made, the respective firm and their biologic drug
product(s) will be removed from detention.
GUIDANCE : Districts may detain without physical examination the
specified biologic drug product(s) from the firms listed in
the attachment to his alert.
FOI : No purging is required.
PREPARED BY: Fredda Shere-Valenti, DIOP, (301) 443-6553.
KEYWORDS : GMPs, Biologic drug, Tetanus toxoid, Blood
Date Loaded
into FIARS : April 12, 1999
ATTACHMENT TO IMPORT ALERT# 57-14 1/26/06
PRODUCT: Tetanus Toxoid Adsorbed;
Typhoid Vaccine Live Oral Ty21a
PRODUCT CODE: 57 BY-06
57 YY-99
PAC: 42R800
COUNTRY:
MANUFACTURER/
SHIPPER:
MANUFACTURER/
SHIPPER ID#:
PRODUCT: All Products (including Whole Blood, Red Blood Cells and
Whole Blood CPDA-1, and Recovered Plasma)
PRODUCT CODE: GPI = "BI"
PAC: 42R800
COUNTRY: Germany (DE)
MANUFACTURER/
SHIPPER: Bavarian Red Cross
Herzog-Heinrich-Strasse 4
D-80336, Munich, Germany
U.S. License #1002-001
MANUFACTURER/
SHIPPER ID#: FEI# 3002545763
NOTE: Bavarian Red Cross operation locations under its
U.S. license #1002:
Bavarian Red Cross
Herzog-Heinrich-Strasse 4
D-80336 Munich, Germany
U.S. License #1002-001
FEI #3002545763
Hoher Kreuz Weg 7
D-93055 Regensburg, Germany
U.S. License #1002-002
FEI # 3002545773
Westheimer Strasse 80
D-86156 Augsburg, Germany
U.S. License #1002-003
FEI # 3002545774
Flurstrasse 17
D-90419 Nuremburg, Germany
U.S. License #1002-004
FEI #3002545776
Klinikstrasse 5
D-97070 Wurzburg, Germany
U.S. License #1002-005
FEI #3002545780
D-95445 Bayreuth, Germany
U.S. License # 1002-006
FEI #3002545781
Nickolaus-Fey-Strasse 32
Wiesentheid, Germany D97353
U.S. License #1002
FEI #3002809545
(Note: The Wiesentheid facility of the Bavarian Red
Cross is a collection, component preparation,
and distribution facility/ center. It is an
auxiliary facility under the Munich location of
the Bavarian Red Cross. If entries are
encountered, contact CBER Import/Export Team at
301-827-6201.
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