IA #57-14, 9/18/00 - 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 10/22/04 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. Chiron Vaccines Influenza Flu Vaccine AKA Evans Vaccines, Inc. 57C[][]02 Gaskill Road Speke 57Y[][]99 Liverpool, L249GR 10/22/04 United Kingdom FEI# 3002806949 Chiron Spa Influenza Flu Vaccine Via Fiorentina 1 57C[][]02 Siena, SI 53100 57Y[][]99 Italy 10/22/04 FEI# 3000218935