Refusal Actions by FDA as Recorded in OASIS for United Kingdom
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Catalent Pharma Solutions
Swindon , GB SN58YG NYK-DO 267-5134511-2/1/1
66VAH99 PRENATE DHA IN BLISTERS OF 5 CAPSULES - SAMPLES
08-JUL-2008 UNAPPROVED
Catalent Pharma Solutions
Swindon , GB SN58YG NYK-DO 267-5134511-2/2/1
66VAM99 PRENATE DHA IN BLISTERS OF 5 CAPSULES - SAMPLES
08-JUL-2008 UNAPPROVED
Baganovo
Barnet , GB EN51RZ NYK-DO DO7-8719848-3/1/1
62ACK05 ZOMETA
10-JUL-2008 NOT LISTED
UNAPPROVED
Schering-Plough House
Welwyn Garden , GB AL71TW NOL-DO 112-3498215-8/1/1
62FAK53 864093171473/NASONEX
21-JUL-2008 UNAPPROVED
Olympus Optical Co., Ltd.
Shinjuku-ku, Tokyo , JP 163-91 NOL-DO 112-3451460-5/1/2
78K--OG 862423896099/ENDOSCOPE
21-JUL-2008 NO 510(K)
Ferring Pharma Ltd
Langley, Berkslangley, Berks , GB SL36EZ NOL-DO 112-3159136-6/1/1
61QCB03 863233145182/DESMOPRESSIN ACETATE0.2MG
21-JUL-2008 UNAPPROVED
Firefly Tonics, Ltd
London GB-LND, GB SW75NR NYK-DO D03-0165374-3/13/1
54ECY12 ENERGY DRINKS-NON-ALCOHOLIC
22-JUL-2008 SBGINSENG
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO T77-1030734-1/4/1
53CH-03 EYE SHADOW (EYE MAKEUP PREPARATIONS);POWDER;
24-JUL-2008 HELD INSAN
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO T77-1031518-7/4/1
53CH-03 EYE SHADOW (EYE MAKEUP PREPARATIONS);POWDER;
24-JUL-2008 HELD INSAN
Pharmadass Limited
Greenford Middlesex, GB SAN-DO 231-8018673-9/1/27
54FBH12 GUARAMAX GUARANA 1000MG BULK 1000'S USA
26-JUL-2008 UNSAFE COL
LIST INGRE
DIETARYLBL
FALSE
LACKS FIRM
LABELING
NUTRIT LBL
Penn Pharmaceuticals Services Ltd.
Tredegar, Gwent, Wales Gwent, GB NP2 3AA PHI-DO SG5-0418821-3/1/1
66VIE99 CC-4047 SPONSOR CELGENE CORP 1, 2 AND 5MGEXPIRED UNUSED STUD
28-JUL-2008 UNAPPROVED
Astra Faam b.v.
Breda NL-NB, NL 4816BG SWI-DO 512-1003900-7/14/1
33SGY99 Wine gums
30-JUL-2008 UNSAFE COL
LACKS N/C
NUTRIT LBL
Metabolics Ltd
Devizes , GB SN104PL NOL-DO 112-3130373-9/1/1A
53LY-01 714393564532 AA CREAM
30-JUL-2008 CSTIC LBLG
LABELING
Bio Care Ltd
Birmingham , GB B303NU NOL-DO 112-3130373-9/1/1B
62WAJ99 714393564532 Cervagyn cream
30-JUL-2008 NOT LISTED
DR QUALITC
Metabolics Ltd
Devizes , GB SN104PL NOL-DO 112-3130373-9/1/1C
53LY-01 714393564532 GAC Cream
30-JUL-2008 CSTIC LBLG
LABELING
Metabolics Ltd
Devizes , GB SN104PL NOL-DO 112-3130373-9/1/2
53LY-01 714393564532 COLLAGEN
31-JUL-2008 COSMETLBLG
Metabolics Ltd
Devizes , GB SN104PL NOL-DO 112-3130373-9/1/3
53LY-01 714393564532 ELASTIN CREAM
31-JUL-2008 LABELING
COSMETLBLG
Metabolics Ltd
Devizes , GB SN104PL NOL-DO 112-3130373-9/1/4
53LY-01 714393564532 GAC CREAM
31-JUL-2008 CSTIC LBLG
LABELING
Metabolics Ltd
Devizes , GB SN104PL NOL-DO 112-3130373-9/2/1
62WAJ99 714393564532 VAGINAL CREAM
31-JUL-2008 NOT LISTED
DR QUALITC
Amdipharm
Essex , GB NOL-DO 112-3160469-8/1/1
62CDZ22 924192468654 GUANETHIDINE MONOSULPHATE
31-JUL-2008 NOT LISTED
UNAPPROVED