IA #57-13, 2/24/99 - IMPORT ALERT #57-13, "DETENTION WITHOUT PHYSICAL EXAMINATION OF
HUMAN NEONATAL KIDNEY CELLS FROM IN VITRO DEPT. OF MICROBIOLOGY,
UNIVERSITY DE VALLE, CALI, COLOMBIA"
TYPE OF ALERT: Detention Without Physical Examination.
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufac
turer
and products at issue. It does not create or confer any rights for or on any person and does not operate to bi
nd FDA or
the public.)
PRODUCT: HUMAN NEONATAL KIDNEY CELLS
PRODUCT CODES: 88KIR (Cells, Animal, Human, Cultured), 57YY-99
PROBLEM: Failure to Meet Drug GMPs
PAC: 42R800
PAF: PER
OASIS CHARGE CODE: DRUG GMPS
COUNTRY: Colombia (CO)
MANUFACTURER/SHIPPER: In Vitro Department of Microbiology
University DeValle
Cali, Colombia, South America
Cra.38 4C-21
FEI #3001976882
FEI #3002584963
FEI #3002520885
CHARGE: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods use
d
in or the facilities or controls used for its manufacture, processing, packing, or holding do not
conform to or are not operated or administered in conformity with current good manufacturing
practice within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.
(OASIS VIOLATION CHARGE: DRUG GMPS)
RECOMMENDING
OFFICE: CBER, Office of Compliance and Biologics Quality
Division of Case Management, HFM-610
REASON FOR
ALERT: FDA has confirmed through establishment inspections that human neonatal kidney cells (HNK
cells) were being imported from In Vitro Department of Microbiology, University de Valle, Cali,
Columbia to the United States for use in the manufacture of an FDA approved drug. HNK cells are
components of a drug, and therefore are drugs as defined by Section 201(g) of the Act. FDA's
inspections revealed that the HNK cells were adulterated within the meaning of Section
501(a)(2)(B) of the Act in that they were not manufactured, processed, packed, or held in
accordance with current good manufacturing practice for drug components.
GUIDANCE: Districts may detain without physical examination all Human Neonatal Kidney Cells (HNK cells)
shipped by In Vitro Department of Microbiology, University de Valle, Cali, Colombia.
Should districts encounter shipments of HNK Cells from the identified manufacturer, or from the
country of Colombia, contact one or all the contact persons listed below for additional information.
CBER, Office of Compliance and Biologics Quality, Import/Export Team at (301) 827-6201, FAX
(301) 594-0940; or, Baltimore District: David Gallant, SCSO, at (410) 962-3590, FAX (410) 962-
2219.
FOI: No Purging Required
PREPARED BY: Marvin A. Blumberg, DIOP, (301) 443-6553
KEYWORDS: Cells, Neonatal, Kidney, Human, In Vitro, Cali, Colombia,Drug, Diagnostic, HNK.
Date Loaded
into FIARS : February 24, 1999
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