Refusal Actions by FDA as Recorded in OASIS for United States
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Global Healing Center
Buechel, KY 40218 CIN-DO 110-0703301-8/1/1
54YCE09 OXYPOWDER,VITAMIN SUPPLEMENT,DELV GLOBAL HEALING CENTER HOUS
05-NOV-2007 POISONOUS
INCONSPICU
Bruce Foods Corporation
New Iberia, LA 70560 NOL-DO N90-0738093-0/1/1
25JEE12 RET. AM. GOODS - CANNED SWEET POTATOES
06-NOV-2007 UNDER PRC
FILTHY
MFR INSAN
Diagnostic Test Group
Boca Raton, FL 33431-7966 DET-DO 110-0640179-4/5/1
81K--HE Clarity Fecal Occult Blood Test Kits
07-NOV-2007 REGISTERED
Centre Biotechnique Avance
Albuquerque, NM 87110-6724 NOL-DO 112-8820425-0/1/1
79G--EX 862017062368 LASER HANDPIECE
07-NOV-2007 NOT LISTED
REGISTERED
NON STD
NO 510(K)
Nutro Products Inc
City Of Industry, CA 91744 NYK-DO 235-8018025-7/1/1
72BFA01 RECALLED PET FOOD
08-NOV-2007 POISONOUS
Nutro Products Inc
City Of Industry, CA 91744 NYK-DO 235-8018025-7/2/1
72BFA05 PET FOOD
08-NOV-2007 POISONOUS
Nutro Products Inc
City Of Industry, CA 91744 NYK-DO 235-8018026-5/1/1
72BFA05 RECALLED PET FOOD
08-NOV-2007 POISONOUS
Centocor Inc
Frazer, PA 19355-1307 NYK-DO AEK-7210195-5/1/1
61LCP15 RETEPALSE RETURN TO SUPPLIER
09-NOV-2007 DE/RX KIT
Douglas Laboratories
Pittsburgh, PA 15205-9742 NYK-DO 101-7602852-9/1/1A
54YCS08 CO ENZYME Q-10
13-NOV-2007 DIETARYLBL
NUTRIT LBL
Spectrum Cosmetics
Commerce, CA 90040-3216 LOS-DO 946-0600587-7/1/3
53LC-06 MOISTURIZING (SKIN CARE PREPARATIONS);CREAM;
14-NOV-2007 NOT LISTED
Pfizer
Kalamazoo, MI 49001-0101 NOL-DO 112-7148159-2/1/1
56IYB76 861610635230.ZITROMAX
16-NOV-2007 UNAPPROVED
Technipak
Greeley, CO 80631-7115 CIN-DO AEK-9051787-7/1/1
54YCA99 DIETARY SUPPLEMENT
19-NOV-2007 HEALTH C
Bristol- Myers Squibb Company
Evansville, IN 47721 SJN-DO BOU-1004839-6/1/1
40CED01 BABY FORMULA (AGR)
19-NOV-2007 NUTR UNIT
The Stevens Co Ltd Bc Division
Delta BC, CA V4G1J6 SEA-DO 110-0477570-2/1/1
80F--RN INFUSION SET
26-NOV-2007 NOT LISTED
NO 510(K)
IsoTis OrthoBiologics, Inc.
Irvine, CA 92618-2053 LOS-DO AEK-7670234-5/1/1
89N--EN HUMAN BONE ALLOGRAFT
27-NOV-2007 NOT LISTED
IsoTis OrthoBiologics, Inc.
Irvine, CA 92618-2053 LOS-DO AEK-7686345-1/1/1
74D--WF CATHETER (FDA REQUESTED FORMAL ENTRY)
27-NOV-2007 NOT LISTED
REGISTERED
Masimo Corporation
Irvine, CA 92618 LOS-DO AEK-7674285-3/1/1
85M--MA PULSE OXIMETER
27-NOV-2007 NOT LISTED