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
Body Jewellery Shop Ltd
Watfordwatford , GB WD18 9DA CIN-DO 110-0478048-8/1/1
86L--PL ERR/CBP-HALLOWEEN CONTACT LENSES-PERSONAL USE/MFR'D IN KOREA
02-NOV-2007 NOT LISTED
REGISTERED
NO 510(K)
Wonderturn Ltd.
Wembley, Middlesex , GB HAO 1SU NYK-DO KM6-0033343-9/8/2
28KGT99 RAJAH TANDOORI MASALA
02-NOV-2007 UNSAFE COL
L. E. West & Co.Ltd
London , GB E16 NOL-DO 112-8795147-1/1/1
78G--BT 949589325738/CATHETER SET
05-NOV-2007 NOT LISTED
NO 510(K)
Fortress Diagnosti
Antrim , GB NOL-DO 112-8835407-1/1/1
88L--DT 857880580321 DIAGNOSTIC REAGENTS
07-NOV-2007 NOT LISTED
Preema Intl Ltd
Middlex , GB UB67JB NYK-DO KM6-0033343-9/12/1B
50BCT01 Red Preema food powder
09-NOV-2007 UNSAFE COL
Preema Intl Ltd
Middlex , GB UB67JB NYK-DO KM6-0033343-9/12/1C
50BCT01 Orange Preema food powder
09-NOV-2007 UNSAFE COL
Steiner Transocean Ltd
Middx , GB HA36BZ FLA-DO MA7-0629415-8/10/1B
53LD-06 Anti wrinkle gel
13-NOV-2007 COSMETLBLG
Steiner Transocean Ltd
Middx , GB HA36BZ FLA-DO MA7-0629415-8/13/1B
65LDJ11 Sun screen (SPF15)
13-NOV-2007 NOT LISTED
Steiner Transocean Ltd
Middx , GB HA36BZ FLA-DO MA7-0629415-8/13/1C
61HCL99 Anti-bacerial
13-NOV-2007 NOT LISTED
LABELING
Steiner Transocean Ltd
Middx , GB HA36BZ FLA-DO MA7-0629415-8/15/1
53MC-01 TANNING LOTION
13-NOV-2007 COSMETLBLG
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO 112-8300445-7/5/1
53CH-03 EYESHADOW
13-NOV-2007 POISONOUS
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO 112-8300445-7/5/2
53CH-03 EYESHADOW
13-NOV-2007 POISONOUS
Seasoners Fine Foods Ltd
Lancashire , GB NYK-DO DP4-0417336-2/12/1
24FCE20 COUNTRY PICKLES
13-NOV-2007 NO PROCESS
Greencore Grocery
North Yorkshire , GB YO85BJ NYK-DO DP4-0417336-2/18/1
37JCE07 HOT HORSERADISH SAUCE
13-NOV-2007 NEEDS FCE
NO PROCESS
Greencore Grocery
North Yorkshire , GB YO85BJ NYK-DO DP4-0417336-2/19/1
37JCE07 MINT SAUCE
13-NOV-2007 NEEDS FCE
NO PROCESS
Jd Harris
Warminster , GB NYK-DO 112-8774041-1/1/1
86H--QG 924191357614 PINEHOLE EYEGLASSES
16-NOV-2007 NOT LISTED
DIRECTIONS
REGISTERED
NO 510(K)
Microtech International Uk Ltd.
West Yorkshire , GB LOS-DO AEK-7691229-0/1/1
66VDA99 HEALTHE FOOD SUPPLEMENT
27-NOV-2007 NOT LISTED
UNAPPROVED
Pharmacy2u
Leedsleeds , GB LS14 1PQ PHI-DO 110-0707733-8/1/3
56YBK99 OPTREX SORE EYES DROPS OTC PERSONAL USE DORIS JOHNSON
28-NOV-2007 UNAPPROVED
Pharmacy2u
Leedsleeds , GB LS14 1PQ PHI-DO 110-0707733-8/1/5
53BH-01 DEAD SEA SPA BATH SALTS PERSONAL USE DORIS JOHNSON
28-NOV-2007 HEALTH C
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545221-3/1/1
37JCI23 SHARWOODS TIKKA MASALA COOK SAUCE
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545221-3/1/2
37JCI23 SHARWOODS MAKHANI COOKING SAUCE
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545221-3/1/3
37JCI23 SHARWOODS KUNG PO COOKING SAUCE
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545221-3/1/4
37JCI23 SHARWOODS INDONESIAN SATAY
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545221-3/1/5
37JCI23 SHARWOODS THAI RED CURRY COOK SAUCE
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545222-1/1/1
37JCI23 SHARWOODS TIKKA MASALA COOK SAUCE
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545222-1/1/2
37JCI23 SHARWOODS MAKHANI COOKING SAUCE
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545222-1/1/3
37JCI23 SHARWOODS INDONESIAN SATAY
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545222-1/4/1
21UCI05 SHARWOODS MAJOR GREY MANGO CHUTNEY
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545222-1/4/2
27YCI03 SHARWOODS MAJGREY MANGO CHUTNEY
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545222-1/4/3
27YCI03 SHARWOODS MANGO & GINGER CHUTNEY
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545239-5/1/1
37JCI23 SHARWOODS TIKKA MASALA COOK SAUCE
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545239-5/1/2
37JCI23 SHARWOODS MAKHANI COOKING SAUCE
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545239-5/1/3
37JCI23 SHARWOODS INDONESIAN SATAY
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545239-5/1/4
37JCI23 SHARWOODS THAI RED CURRY COOK SAUCE
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545239-5/4/1
27YCI03 SHARWOODS BENGAL SPICE CHUTNEY
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545239-5/4/2
27YCI03 SHARWOODS MAJOR GREY MANGO CHUTNEY
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545239-5/4/3
27YCI03 SHARWOODS MAJGREY MANGO CHUTNEY
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545287-4/1/1
37JCI99 SHARWOODS TIKKA MASALA COOK SAUCE
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545287-4/1/2
37JCI99 SHARWOODS KUNG PO COOKING SAUCE
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545287-4/1/3
37JCI23 SHARWOODS BLK BEAN & RED PEPPER COOK SAUCE
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545287-4/1/4
37JCI23 SHARWOODS THAI RED CURRY COOK SAUCE
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545287-4/3/1
27YCI03 SHARWOODS BENGAL SPICE CHUTNEY
28-NOV-2007 NEEDS FCE
NO PROCESS
Centura Foods Ltd
Droylsden , GB M436DR NWE-DO 144-9545287-4/3/2
27YCI03 SHARWOODS MAJOR GREY MANGO CHUTNEY
28-NOV-2007 NEEDS FCE
NO PROCESS
The Sun Studio
Withamwitham , GB CM081 PHI-DO 110-0509586-0/1/1
66VDK99 DETOX FOOT PATCHES BODYTOX
29-NOV-2007 UNAPPROVED