Refusal Actions by FDA as Recorded in OASIS
Manufacturer FEI: 3001451800
Manufacturer Name: CG Laboratories, Inc
Manufacturer address line 1: 1410 Southtown Dr
Manufacturer address line 2:
Manufacturer City: Granbury
Manufacturer Province/state: TX
Manufacturer Country: United States
Product code: 79G--AG
Importers product description: 863168391134 PROXIMATE STAPLER
Refusal date: 06-NOV-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: 112-4933339-7/2/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3005880868
Manufacturer Name: Yangtze Development Ind Ltd
Manufacturer address line 1: 26f Wenhua Buildshennan East Rd
Manufacturer address line 2:
Manufacturer City: Shenzhenshenzhen
Manufacturer Province/state:
Manufacturer Country: China
Product code: 79G--EM
Importers product description: 2X2 GAUZE SPONGE
Refusal date: 14-NOV-2008
FDA_District: NWE-DO
Entry/doc/line/sfx: 551-6390460-5/1/1/
Carrier: NEW PENN MOTOR EXPRESS INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3005880868
Manufacturer Name: Yangtze Development Ind Ltd
Manufacturer address line 1: 26f Wenhua Buildshennan East Rd
Manufacturer address line 2:
Manufacturer City: Shenzhenshenzhen
Manufacturer Province/state:
Manufacturer Country: China
Product code: 79G--EM
Importers product description: 2X2 12 PLY GAUZE SPONGE
Refusal date: 14-NOV-2008
FDA_District: NWE-DO
Entry/doc/line/sfx: 551-6390460-5/2/1/
Carrier: NEW PENN MOTOR EXPRESS INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3005880868
Manufacturer Name: Yangtze Development Ind Ltd
Manufacturer address line 1: 26f Wenhua Buildshennan East Rd
Manufacturer address line 2:
Manufacturer City: Shenzhenshenzhen
Manufacturer Province/state:
Manufacturer Country: China
Product code: 79G--EM
Importers product description: 4X4 8 PLY GAUZE ESPONGE
Refusal date: 14-NOV-2008
FDA_District: NWE-DO
Entry/doc/line/sfx: 551-6390460-5/3/1/
Carrier: NEW PENN MOTOR EXPRESS INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3005880868
Manufacturer Name: Yangtze Development Ind Ltd
Manufacturer address line 1: 26f Wenhua Buildshennan East Rd
Manufacturer address line 2:
Manufacturer City: Shenzhenshenzhen
Manufacturer Province/state:
Manufacturer Country: China
Product code: 79G--EM
Importers product description: 4X8 12 PLY GAUZE SPONGE
Refusal date: 14-NOV-2008
FDA_District: NWE-DO
Entry/doc/line/sfx: 551-6390460-5/4/1/
Carrier: NEW PENN MOTOR EXPRESS INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3005880868
Manufacturer Name: Yangtze Development Ind Ltd
Manufacturer address line 1: 26f Wenhua Buildshennan East Rd
Manufacturer address line 2:
Manufacturer City: Shenzhenshenzhen
Manufacturer Province/state:
Manufacturer Country: China
Product code: 79G--EM
Importers product description: 4X8 8 PLY GAUZE SPONGE
Refusal date: 14-NOV-2008
FDA_District: NWE-DO
Entry/doc/line/sfx: 551-6390460-5/5/1/
Carrier: NEW PENN MOTOR EXPRESS INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3005880868
Manufacturer Name: Yangtze Development Ind Ltd
Manufacturer address line 1: 26f Wenhua Buildshennan East Rd
Manufacturer address line 2:
Manufacturer City: Shenzhenshenzhen
Manufacturer Province/state:
Manufacturer Country: China
Product code: 79G--EM
Importers product description: 4X8 12 PLY GAUZE SPONGE
Refusal date: 14-NOV-2008
FDA_District: NWE-DO
Entry/doc/line/sfx: 551-6390460-5/6/1/
Carrier: NEW PENN MOTOR EXPRESS INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3005880868
Manufacturer Name: Yangtze Development Ind Ltd
Manufacturer address line 1: 26f Wenhua Buildshennan East Rd
Manufacturer address line 2:
Manufacturer City: Shenzhenshenzhen
Manufacturer Province/state:
Manufacturer Country: China
Product code: 79G--EM
Importers product description: 12X12 LAPAROTOMY SPONGE
Refusal date: 14-NOV-2008
FDA_District: NWE-DO
Entry/doc/line/sfx: 551-6390460-5/7/1/
Carrier: NEW PENN MOTOR EXPRESS INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3005880868
Manufacturer Name: Yangtze Development Ind Ltd
Manufacturer address line 1: 26f Wenhua Buildshennan East Rd
Manufacturer address line 2:
Manufacturer City: Shenzhenshenzhen
Manufacturer Province/state:
Manufacturer Country: China
Product code: 79G--EM
Importers product description: 2X2 6 PLY STERILE SPONGE
Refusal date: 14-NOV-2008
FDA_District: NWE-DO
Entry/doc/line/sfx: 551-6390460-5/8/1/
Carrier: NEW PENN MOTOR EXPRESS INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3005880868
Manufacturer Name: Yangtze Development Ind Ltd
Manufacturer address line 1: 26f Wenhua Buildshennan East Rd
Manufacturer address line 2:
Manufacturer City: Shenzhenshenzhen
Manufacturer Province/state:
Manufacturer Country: China
Product code: 79G--EM
Importers product description: 4X4 4 PLY NON WOVEN GAUZE SPONGE
Refusal date: 14-NOV-2008
FDA_District: NWE-DO
Entry/doc/line/sfx: 551-6390460-5/9/1/
Carrier: NEW PENN MOTOR EXPRESS INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3005880868
Manufacturer Name: Yangtze Development Ind Ltd
Manufacturer address line 1: 26f Wenhua Buildshennan East Rd
Manufacturer address line 2:
Manufacturer City: Shenzhenshenzhen
Manufacturer Province/state:
Manufacturer Country: China
Product code: 79G--EM
Importers product description: 8X10 STERILE A B D PADS
Refusal date: 14-NOV-2008
FDA_District: NWE-DO
Entry/doc/line/sfx: 551-6390460-5/14/1/
Carrier: NEW PENN MOTOR EXPRESS INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3005034090
Manufacturer Name: Ningbo Free Zone Chain Medical Prod
Manufacturer address line 1: Room B3-B4, Fl10, No.72 Ma Yuan Rd.
Manufacturer address line 2:
Manufacturer City: Ningbo
Manufacturer Province/state:
Manufacturer Country: China
Product code: 79G--EM
Importers product description: 4X4 6 PLY STERILE DRAIN SPONGE
Refusal date: 14-NOV-2008
FDA_District: NWE-DO
Entry/doc/line/sfx: 551-6390460-5/15/1/
Carrier: NEW PENN MOTOR EXPRESS INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3005034090
Manufacturer Name: Ningbo Free Zone Chain Medical Prod
Manufacturer address line 1: Room B3-B4, Fl10, No.72 Ma Yuan Rd.
Manufacturer address line 2:
Manufacturer City: Ningbo
Manufacturer Province/state:
Manufacturer Country: China
Product code: 79G--EM
Importers product description: 2X2 12 PLY STERILE GAUZE SPONGE
Refusal date: 14-NOV-2008
FDA_District: NWE-DO
Entry/doc/line/sfx: 551-6390460-5/16/1/
Carrier: NEW PENN MOTOR EXPRESS INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3005034090
Manufacturer Name: Ningbo Free Zone Chain Medical Prod
Manufacturer address line 1: Room B3-B4, Fl10, No.72 Ma Yuan Rd.
Manufacturer address line 2:
Manufacturer City: Ningbo
Manufacturer Province/state:
Manufacturer Country: China
Product code: 79G--EM
Importers product description: 4X4 8 PLY STERILE GAUZE SPONGE
Refusal date: 14-NOV-2008
FDA_District: NWE-DO
Entry/doc/line/sfx: 551-6390460-5/17/1/
Carrier: NEW PENN MOTOR EXPRESS INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3005034090
Manufacturer Name: Ningbo Free Zone Chain Medical Prod
Manufacturer address line 1: Room B3-B4, Fl10, No.72 Ma Yuan Rd.
Manufacturer address line 2:
Manufacturer City: Ningbo
Manufacturer Province/state:
Manufacturer Country: China
Product code: 79G--EM
Importers product description: 4X4 12 PLY STERILE GAUZE SPONGE
Refusal date: 14-NOV-2008
FDA_District: NWE-DO
Entry/doc/line/sfx: 551-6390460-5/18/1/
Carrier: NEW PENN MOTOR EXPRESS INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3005034090
Manufacturer Name: Ningbo Free Zone Chain Medical Prod
Manufacturer address line 1: Room B3-B4, Fl10, No.72 Ma Yuan Rd.
Manufacturer address line 2:
Manufacturer City: Ningbo
Manufacturer Province/state:
Manufacturer Country: China
Product code: 79G--EM
Importers product description: 4X4 12 PLY STERILE GAUZE SPONGE
Refusal date: 14-NOV-2008
FDA_District: NWE-DO
Entry/doc/line/sfx: 551-6390460-5/19/1/
Carrier: NEW PENN MOTOR EXPRESS INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3001451800
Manufacturer Name: CG Laboratories, Inc
Manufacturer address line 1: 1410 Southtown Dr
Manufacturer address line 2:
Manufacturer City: Granbury
Manufacturer Province/state: TX
Manufacturer Country: United States
Product code: 79L--FL
Importers product description: 863168391134 CURVED SEARS
Refusal date: 06-NOV-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: 112-4933339-7/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3001451800
Manufacturer Name: CG Laboratories, Inc
Manufacturer address line 1: 1410 Southtown Dr
Manufacturer address line 2:
Manufacturer City: Granbury
Manufacturer Province/state: TX
Manufacturer Country: United States
Product code: 79L--FL
Importers product description: 863168391134 ULTRACISION COAGULATION SHE
Refusal date: 06-NOV-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: 112-4933339-7/1/2/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3007175562
Manufacturer Name: Techwaxy
Manufacturer address line 1: 850 Superior St
Manufacturer address line 2:
Manufacturer City: Windsor
Manufacturer Province/state: ON
Manufacturer Country: Canada
Product code: 79N--OC
Importers product description: SAM Splint
Refusal date: 24-NOV-2008
FDA_District: DET-DO
Entry/doc/line/sfx: KB5-5193971-7/18/1/D
Carrier: DELL WILL CUSTOMS BROKERS USA
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
Manufacturer FEI: 3007175562
Manufacturer Name: Techwaxy
Manufacturer address line 1: 850 Superior St
Manufacturer address line 2:
Manufacturer City: Windsor
Manufacturer Province/state: ON
Manufacturer Country: Canada
Product code: 79O--HO
Importers product description: First Aid Kit
Refusal date: 24-NOV-2008
FDA_District: DET-DO
Entry/doc/line/sfx: KB5-5193971-7/18/1/A
Carrier: DELL WILL CUSTOMS BROKERS USA
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED