Refusal Actions by FDA as Recorded in OASIS for Ecuador
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
ECUAMINOT S.A
Quito EC-P, EC 0001 SWI-DO 601-0147119-5/1/1
16AEE33 SARDINES FISH
05-JUN-2008 HISTAMINE
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/1
52AII29 FFL TRAY#2
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/2
52AII29 LC1 TRAY
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/3
52AII29 PBN TRAY
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/4
52AII29 PC2 TRAY
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/5
52AII29 PF7 TRAY
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/6
52AII29 PUF TRAY
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/7
52AII29 SAL TRAY
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/8
52AII28 AUG PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/9
52AII28 FFL PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/10
52AII28 FPE PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/11
52AII28 GD1 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/12
52AII28 GRB PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/13
52AII28 LC1 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/14
52AII28 MOO PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/15
52AII28 ORC PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/16
52AII28 PBD PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/17
52AII28 PBN PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/18
52AII28 PC2 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/19
52AII28 PF1 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/20
52AII28 PF2 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/21
52AII28 PF4 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/22
52AII28 PF5
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/23
52AII28 PF6 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/24
52AII28 PF7 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/25
52AII28 PL1 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/26
52AII28 PUF PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/27
52AII28 RAV PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/28
52AII28 SAL PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/29
52AII28 WHA PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/2/30
52AII28 WP2 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/1
52AII28 AGU PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/2
52AII28 GRB PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/3
52AII28 LC1 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/4
52AII28 PBN PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/5
52AII28 PC2 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/6
52AII28 PF1 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/7
52AII28 PF2 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/8
52AII28 PF4 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/9
52AII28 PF5 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/10
52AII28 PF6 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/11
52AII28 PF7 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/12
52AII28 PL1 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/13
52AII28 PUF PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/14
52AII28 SAL PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/15
52AII28 STA PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/16
52AII28 STD PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/17
52AII28 WHA PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/18
52AII28 AA1 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/19
52AII28 CL1 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/20
52AII28 LC2 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/21
52AII28 PF1 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/22
52AII28 PF3 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/23
52AII28 PF4 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/24
52AII28 PG3 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/25
52AII28 SR1 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/26
52AII28 SR2 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/27
52AII28 WP2 PLATE
13-JUN-2008 UNSAFE ADD
Mythos Native Art
Quito , EC SEA-DO EU7-2800679-9/8/28
52AII28 FFL PLATE
13-JUN-2008 UNSAFE ADD
Emcopac S.A. (Empacadora Coral del Pacifico)
Esmeralda EC-E, EC None FLA-DO HQ7-0041317-7/3/1
16AGC42 SWORD FISH FRESH
24-JUN-2008 POISONOUS
Emcopac S.A. (Empacadora Coral del Pacifico)
Esmeralda EC-E, EC None FLA-DO HQ7-0041318-5/2/1
16AGC42 SWOWRDFISH HG
24-JUN-2008 POISONOUS
Promarisco S.A.
Guayaquil , EC 1234 NYK-DO 750-0122925-3/3/1
16JGD05 FARMDELIGHT RAW HL 41-50
Partial Refusal 24-JUN-2008 FILTHY