2004년 11월

Dong Wha Pharmaceutical Industries Co., Ltd.

Seoul , KR 100130                              LOS-DO  WNS-0240637-0/1/1

31KCY99   GAS WHAL MYUNG SU-Q

22-NOV-2004                        NO PROCESS

2004년 10월

Hanmi Co.,Ltd

Kyunggido , KR                                 LOS-DO  WRE-0324206-2/27/1

29AHT99   NON CARBONATED DRINKS (ALOE MINE)

19-OCT-2004                        NEEDS FCE

2004년 9월

Chonggeundang Pharmaceutical

Seoul , KR                                     DET-DO  112-4429248-8/3/1

60SCA99   848560937019 BETAZYME

15-SEP-2004                        UNAPPROVED

Dong-A Pharmaceutical Co., Ltd.

Seoul , KR                                     DET-DO  112-4429248-8/3/2

60SCC99   848560937019  GASTER

15-SEP-2004                        UNAPPROVED

Hwanin Pharmaceutical

Seoul , KR                                     DET-DO  112-4429248-8/5/1

56ICC10   848560937019 ERYTHROMICIN PROPIONATE

15-SEP-2004                        UNAPPROVED

Janssen Pharmaceutica

Seoul , KR                                     DET-DO  112-4429248-8/6/1

66VIA99   Unknown Tablets #322-8905

15-SEP-2004                        DIRECTIONS

LACKS FIRM

INCONSPICU

NO ENGLISH

DRUG NAME

UNAPPROVED

Samkong Pharm Co., Ltd.

Kyunggi-Do , KR                                LOS-DO  WNS-0231066-3/1/1

66VBO99   TOCOPHEROL, SQUALENE BANJIL CREAM

18-SEP-2004                        NOT LISTED

Chong Kun Dang Pharmaceutical Corp.

Ansan City, Kyong-gi , KR 1234                 LOS-DO  AJ1-0233075-7/1/1

66VBC99   S-MEDICHEONGKOOK

23-SEP-2004                        NOT LISTED

FALSE

2004년 8월

Boryung Pharmaceutical Co Ltd

Seoul  , KR 150103                             LOS-DO  AEK-7422931-7/1/1

56HC-25   DAUNORUBICIN HYDROCHLORIDE

04-AUG-2004                        UNAPPROVED

Korea United Pharm Inc

Seoul , KR                                     LOS-DO  WRE-0322551-3/2/1

66VBH99   GERIRAN CAP

09-AUG-2004                        NOT LISTED

UNAPPROVED

Korea United Pharm Inc

Seoul , KR                                     LOS-DO  WRE-0322551-3/2/2

66VBH99   ALKAFEN NASAL CAP

09-AUG-2004                        NOT LISTED

UNAPPROVED

Korea United Pharm Inc

Seoul , KR                                     LOS-DO  WRE-0322551-3/2/3

66VBH99   CEROTEC 10MG TAB

09-AUG-2004                        NOT LISTED

UNAPPROVED

Shin Poong Pharmaceutical Co

Seoul , KR                                     LOS-DO  AEK-7420127-4/1/1

66VCL99   DISKEN INJ 4000 UNITS

16-AUG-2004                        UNAPPROVED

Viva Pharmaceutical Inc

Richmond BC, CA V6V1K8                         SEA-DO  582-7401288-9/1/1

54FYR12   GINSENG POWDER

25-AUG-2004                        PESTICIDES

LG Household & Health Care Ltd.

Seoul , KR 150-721                             LOS-DO  HD8-0068860-2/3/3

66VBY99   WHITE FOCUS INTENSIVE WHITENING TREATMENT   EL-1

25-AUG-2004                        UNAPPROVED

2004년 7월

Sang A Pharm. Co Ltd

Seoul , KR                                     SEA-DO  178-6004214-6/14/1

79K--GX   BANDAGE (BAND AID)

07-JUL-2004                        NOT LISTED

Yuhan Medica Corp

Kyounggi Do , KR                               LOS-DO  AYU-1001399-1/16/1

29YGY99   SWEET SOFT DRINK

07-JUL-2004                        NEEDS FCE

Hanmi Ci., Ltd.

Gyeonggi-Do, Korea , KR                        BLT-DO  M98-0067040-5/9/1

29AGT99   ASSI GOOD MORNING

20-JUL-2004                        NO PROCESS

2004년 6월

Samsung Pharm Ind Co Ltd

Seoul , KR                                     LOS-DO  AYU-1000789-4/1/1

66VBR99   HERBAL DRINK

07-JUN-2004                        LABELING

Dong Sung Pharm. Co

Seoul , KR                                     LOS-DO  AYU-7000098-7/1/1B

66VBJ99   A Clear Cream

07-JUN-2004                        NOT LISTED

2004년 5월

Yuhan Corporation

Seoul , KR                                     DET-DO  112-3194544-5/1/1

64LAO03   844603747600 CELESTONE-G

10-MAY-2004                        PERSONALRX

UNAPPROVED

Reason: UNAPPROVED

Section: 505(a), 801(a)(3); UNAPPROVED NEW DRUG

Charge: The article appears to be a new drug without an

approved new drug application.

Reason: NOT LISTED

Section: 502(o), 801(a)(3); MISBRANDING

Charge: It appears the drug or device is not included in a

list required by Section 510(j), or a notice or other

information respecting it was not provided as required by

section 510(j) or 510(k).

Reason: NO PROCESS

Section: 402(a)(4), 801(a)(3); ADULTERATION

Charge: It appears that the manufacturer has not filed

information on its scheduled process as required by 21 CFR

108.25(c)(2) or 108.35(c)(2).

Reason: NEEDS FCE

Section: 402(a)(4), 801(a)(3); ADULTERATION

Charge: It appears the manufacturer is not registered as a

low acid canned food or acidified food manufacturer pursuant

to 21 CFR 108.25(c)(1) or 108.35(c)(1).

Reason: DIRECTIONS

Section: 502(f)(1), 801(a)(3); MISBRANDING

Charge: The article appears to lack adequate directions for

use.

Reason: LACKS FIRM

Section: 502(b)(1), 801(a)(3); MISBRANDING

Charge: The article is in package form and appears to not

bear a label containing the name and place of business of

the manufacturer, packer, or distributor.

Reason: INCONSPICU

Section: 502(c), 801(a)(3); MISBRANDING

Charge: Information required by the Act to be on the label

or labeling does not appear to be conspicuous enough as to

render it likely to be read and understood by the ordinary

individual under customary conditions of purchase and use.

Reason: NO ENGLISH

Section: 502(c); 801(a)(3) ;MISBRANDING

Charge: Required label or labeling appears to not be in

English in violation of 21 C.F.R. 201.15(c)(1).

Reason: DRUG NAME

Section: 502(e)(1); 801(a)(3); Misbranding

Charge: The article appears to be a drug and fails to bear

the proprietary or established name and/or name and quantity

of each active ingredient.

Reason: PESTICIDES

Section: 402(a)(2)(B), 802(a)(B); ADULTERATION

Charge: The article is subject to refusal of admission

pursuant to section 801(a)(3) in that it appears to be

adulterated because it contains a pesticide chemical, which

is in violation of section 402(a)(2)(B). Contains:

Reason: LABELING

Section: Section 4(a); 801(a)(3) Misbranding

Charge: The article appears in violation of FPLA because of

its placement, form and/or contents statement.

Reason: PERSONALRX

Section: 502(a) & (f)(1), 801(a)(3); MISBRANDING

Charge: The article appears to be a drug which requires a

prescription from your doctor.