Import Alert 57-14
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(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).
Import Alert # 57-14
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Biologic Drugs From Firms That Have Not Met Drug GMPs"
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 Red List in this alert.
Product Description:
Various biologic drugs (see Firm/Product)
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)."
OASIS charge code - DRUG GMPS
OASIS charge code - DRUG GMPS
GERMANY
Bavarian Red Cross - Augsburg
Date Published : 09/10/2009
Westheimer Strasse 80 , Augsburg, GERMANY
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 09/10/2009
66 U - - 01 Bone Parts (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 02 Cornea (Eye Parts) (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 03 Embryo (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 04 Hair (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 05 Heart (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 06 Kidney (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 07 Skin (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 08 Sperm (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 99 Natural Body Parts, Invivo Only, N.E.C.
Date Published: 09/10/2009
Bavarian Red Cross - Bayreuth
Date Published : 09/10/2009
Dr. Franz-Strasse 3 , Bayreuth, GERMANY
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 09/10/2009
66 U - - 01 Bone Parts (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 02 Cornea (Eye Parts) (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 03 Embryo (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 04 Hair (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 05 Heart (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 06 Kidney (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 07 Skin (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 08 Sperm (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 99 Natural Body Parts, Invivo Only, N.E.C.
Date Published: 09/10/2009
Bavarian Red Cross - Munich
Date Published : 09/10/2009
Herzog-Heinrich Strasse 4 , Munich, GERMANY
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 09/10/2009
66 U - - 01 Bone Parts (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 02 Cornea (Eye Parts) (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 03 Embryo (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 04 Hair (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 05 Heart (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 06 Kidney (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 07 Skin (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 08 Sperm (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 99 Natural Body Parts, Invivo Only, N.E.C.
Date Published: 09/10/2009
Bavarian Red Cross - Nurnberg
Date Published : 09/10/2009
Prof. Ernst Nathan Str. 1 , Nurnberg, GERMANY
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 09/10/2009
66 U - - 01 Bone Parts (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 02 Cornea (Eye Parts) (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 03 Embryo (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 04 Hair (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 05 Heart (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 06 Kidney (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 07 Skin (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 08 Sperm (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 99 Natural Body Parts, Invivo Only, N.E.C.
Date Published: 09/10/2009
Bavarian Red Cross - Regensburg
Date Published : 09/10/2009
Hoher Kreuz Weg 7 , Regensburg, GERMANY
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 09/10/2009
66 U - - 01 Bone Parts (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 02 Cornea (Eye Parts) (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 03 Embryo (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 04 Hair (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 05 Heart (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 06 Kidney (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 07 Skin (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 08 Sperm (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 99 Natural Body Parts, Invivo Only, N.E.C.
Date Published: 09/10/2009
Bavarian Red Cross - Wiesentheid
Date Published : 09/10/2009
Nikolaus-Fey-Strasse 32 , Wiesentheid, GERMANY
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 09/10/2009
66 U - - 01 Bone Parts (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 02 Cornea (Eye Parts) (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 03 Embryo (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 04 Hair (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 05 Heart (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 06 Kidney (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 07 Skin (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 08 Sperm (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 99 Natural Body Parts, Invivo Only, N.E.C.
Date Published: 09/10/2009
Bavarian Red Cross - Wurzburg
Date Published : 09/10/2009
Klinikstrasse 5 , Wurzburg, GERMANY
57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag
Date Published: 09/10/2009
66 U - - 01 Bone Parts (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 02 Cornea (Eye Parts) (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 03 Embryo (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 04 Hair (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 05 Heart (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 06 Kidney (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 07 Skin (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 08 Sperm (Natural Body Parts, Invivo Only)
Date Published: 09/10/2009
66 U - - 99 Natural Body Parts, Invivo Only, N.E.C.
Date Published: 09/10/2009
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