Itchmo Forums for Cats & Dogs Brought to you by Itchmo: Essential news, humor and info for cats, dogs and pet owners.
November 20, 2019, 05:11:16 AM *
Welcome, Guest. Please login or register.

Login with username, password and session length
News:
 
   Home   Help Search Login Register  

Go To Itchmo.com: Read the latest cat, dog and pet news, pet food recall info, product reviews and more — updated daily.


Pages: [1]
  Print  
Author Topic: FDA OASIS refusals January 2012  (Read 1878 times)
0 Members and 1 Guest are viewing this topic.
menusux
Hero Member
*****
Posts: 4456



« on: February 06, 2012, 08:07:28 AM »

http://www.accessdata.fda.gov/scripts/importrefusals/ir_detail.cfm?EntryId=916-2253167-0&DocId=1&LineId=1&SfxId=

Manufacturer FEI 3006723735
Manufacturer Name Mars Petcare   
Manufacturer Address line 1 Branch No. 1,799 Moo 4   
Manufacturer Address line 2   
Manufacturer's City Pakchong   
Manufacturer Province/State   
Manufacturer Country/Area Thailand    
Product Code 72AGE05   
Importer's Product Description WKS MULTI PACK    (Whiskas)
Refusal Date 25-Jan-2012   
FDA District LOS-DO   
Entry/doc/line/sfx 916-2253167-0/1/1
FDA Sample Analysis No   
FDA Record of Private Lab Sample Analysis No   
Charge(s) Violation Code Section Charge Statement
NO PROCESS   402(a)(4), 801(a)(3); ADULTERATION   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).   
There are two more refusals for the same problem:

http://www.accessdata.fda.gov/scripts/importrefusals/ir_detail.cfm?EntryId=916-2253167-0&DocId=2&LineId=1&SfxId=

Manufacturer FEI 3006723735
Manufacturer Name Mars Petcare   
Manufacturer Address line 1 Branch No. 1,799 Moo 4   
Manufacturer Address line 2   
Manufacturer's City Pakchong   
Manufacturer Province/State   
Manufacturer Country/Area Thailand    
Product Code 72AGE05   
Importer's Product Description WKS PURRECTLY CHICKEN    (Whiskas)
Refusal Date 25-Jan-2012   
FDA District LOS-DO   
Entry/doc/line/sfx 916-2253167-0/2/1
FDA Sample Analysis No   
FDA Record of Private Lab Sample Analysis No   
Charge(s) Violation Code Section Charge Statement
NO PROCESS   402(a)(4), 801(a)(3); ADULTERATION   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).    

http://www.accessdata.fda.gov/scripts/importrefusals/ir_detail.cfm?EntryId=916-2253167-0&DocId=3&LineId=1&SfxId=

Manufacturer FEI 3006723735
Manufacturer Name Mars Petcare   
Manufacturer Address line 1 Branch No. 1,799 Moo 4   
Manufacturer Address line 2   
Manufacturer's City Pakchong   
Manufacturer Province/State   
Manufacturer Country/Area Thailand   
Product Code 72AGE05   
Importer's Product Description WKS PURRECTLY CHICKEN   (Whiskas)
Refusal Date 25-Jan-2012   
FDA District LOS-DO   
Entry/doc/line/sfx 916-2253167-0/3/1
FDA Sample Analysis No   
FDA Record of Private Lab Sample Analysis No   
Charge(s) Violation Code Section Charge Statement
NO PROCESS   402(a)(4), 801(a)(3); ADULTERATION   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).   
 


Remember the Evangers situation with the low acid canning and their non-compliance with it?  This problem also deals with permits and approved processes for canning low acid foods:


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=108.25

21 CFR 108.25 (c)(2)

(2)Process filing. A commercial processor engaged in the processing of acidified foods shall, not later than 60 days after registration, and before packing any new product, provide the Food and Drug Administration information on the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels and source and date of the establishment of the process, for each acidified food in each container size. Filing of this information does not constitute approval of the information by the Food and Drug Administration, and information concerning processes and other data so filed shall be regarded as trade secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905. This information shall be submitted on form FDA 2541a (food canning establishment process filing form for all methods except aseptic). Forms are available from the LACF Registration Coordinator (HFS-618), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at Food and Drug Administration district office. The completed form shall be submitted to the LACF Registration Coordinator (HFS-618), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.


http://google2.fda.gov/search?q=cache:__NFrXKTLxwJ:www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm%3Ffr%3D108.35+21+CFR+108.35&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&ie=UTF-8&access=p&oe=UTF-8

Google cache for this as the FDA page isn't working right now:

21 CFR 108.35(c)(2)

(2)Process filing. A commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers shall, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including but not limited to the processing method, type of retort or other thermal processing equipment employed, minimum initial temperatures, times and temperatures of processing, sterilizing value (Fo), or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process, for each such low-acid food in each container size:Provided, That the filing of such information does not constitute approval of the information by the Food and Drug Administration, and that information concerning processes and other data so filed shall be regarded as trade secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905. This information shall be submitted on the following forms as appropriate: Form FDA 2541a (food canning establishment process filing for all methods except aseptic), or Form FDA 2541c (food canning establishment process filing for aseptic systems). These forms are available from the LACF Registration Coordinator (HFS-618), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at any Food and Drug Administration district office. The completed form(s) shall be submitted to the LACF Registration Coordinator (HFS-618), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.

So Mars tried bringing in made in Thailand product to the US and didn't do the paperwork.   Angry
Logged
menusux
Hero Member
*****
Posts: 4456



« Reply #1 on: February 06, 2012, 08:12:00 AM »

http://www.accessdata.fda.gov/scripts/importrefusals/ir_detail.cfm?EntryId=NV3-0044062-9&DocId=1&LineId=1&SfxId=B

Manufacturer FEI 3008776796
Manufacturer Name Peter'S Petfood & Treats Ltd.    
Manufacturer Address line 1 Estrada Marginal Da Ilha Verde N 62 Edif   
Manufacturer Address line 2   
Manufacturer's City Andar   
Manufacturer Province/State   
Manufacturer Country/Area Macau SAR   
Product Code 72EFB99   
Importer's Product Description POP CORN CHEWS ASSORTMENT    
Refusal Date 12-Jan-2012   
FDA District LOS-DO   
Entry/doc/line/sfx NV3-0044062-9/1/1/B
FDA Sample Analysis Yes   
FDA Record of Private Lab Sample Analysis No   
Charge(s) Violation Code Section Charge Statement
COLOR LBLG   403(k), 801(a)(3); MISBRANDING   The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.   
UNSAFE COL   402(c), 801(a)(3); ADULTERATION   The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).   
 


These look to be dog treats and there are more varieties with the same issues:

http://www.accessdata.fda.gov/scripts/importrefusals/ir_detail.cfm?EntryId=NV3-0044062-9&DocId=4&LineId=1&SfxId=A

Importer's Product Description ASSORTED CHEW    

http://www.accessdata.fda.gov/scripts/importrefusals/ir_detail.cfm?EntryId=NV3-0044062-9&DocId=4&LineId=1&SfxId=B

Importer's Product Description ASSORTED CHEW   

http://www.accessdata.fda.gov/scripts/importrefusals/ir_detail.cfm?EntryId=NV3-0044062-9&DocId=3&LineId=1&SfxId=

Importer's Product Description TREAT BALLS   

http://www.accessdata.fda.gov/scripts/importrefusals/ir_detail.cfm?EntryId=NV3-0044062-9&DocId=9&LineId=1&SfxId=

Importer's Product Description COCONUT CHEWS   
Logged
menusux
Hero Member
*****
Posts: 4456



« Reply #2 on: February 06, 2012, 08:18:39 AM »

http://www.accessdata.fda.gov/scripts/importrefusals/ir_detail.cfm?EntryId=112-5250234-4&DocId=1&LineId=1&SfxId=

Manufacturer FEI 1000189662
Manufacturer Name Five Heros Pet Industries Inc   
Manufacturer Address line 1 No 8 Alley 89 Lane 36   
Manufacturer Address line 2   
Manufacturer's City Taipei   
Manufacturer Province/State   
Manufacturer Country/Area Taiwan   
Product Code 72AGT99   
Importer's Product Description 795437845781 KOI FISH FOOD 12 KG   
Refusal Date 03-Jan-2012   
FDA District DET-DO   
Entry/doc/line/sfx 112-5250234-4/1/1
FDA Sample Analysis No   
FDA Record of Private Lab Sample Analysis No   
Charge(s) Violation Code Section Charge Statement
MELAMINE   402(a)(2)(C)(i), 801(a)(3); ADULTERATION   The article appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409 [Adulteration, section 402(a)(2)(C)(i)].   
POISONOUS   402(a)(1), 801(a)(3); ADULTERATION   The article appears to contain a poisonous or deleterious substance which may render it injurious to health.   
 



http://www.accessdata.fda.gov/scripts/importrefusals/ir_detail.cfm?EntryId=336-0342105-2&DocId=1&LineId=1&SfxId=

Manufacturer FEI 3009220251
Manufacturer Name Aristavet Veterinaer Gmbh & Co   
Manufacturer Address line 1 Banneggstr 88   
Manufacturer Address line 2   
Manufacturer's City Ravensburg   
Manufacturer Province/State   
Manufacturer Country/Area Germany   
Product Code 72EHT99   
Importer's Product Description PANAID POWDER(FEED SUPPLEMENT FOR DOGS AND CATS)   
Refusal Date 24-Jan-2012   
FDA District NYK-DO   
Entry/doc/line/sfx 336-0342105-2/1/1
FDA Sample Analysis No   
FDA Record of Private Lab Sample Analysis No   
Charge(s) Violation Code Section Charge Statement
MFR INSAN   801(a)(1); INSANITARY MANUFACTURING, PROCESSING OR PACKING   The article appears to have been manufactured, processed, or packed under insanitary conditions.   
 
This looks to be pancreatic replacement for those with exocrine pancreatic insufficiency.



http://www.accessdata.fda.gov/scripts/importrefusals/ir_detail.cfm?EntryId=AEK-0021215-5&DocId=1&LineId=1&SfxId=

Manufacturer FEI 3004653802
Manufacturer Name HILTON HERBS LTD   
Manufacturer Address line 1 DOWNCLOSE FARM   
Manufacturer Address line 2 DOWNCLOSE LANE   
Manufacturer's City Crewkerne   
Manufacturer Province/State GB-SOM   
Manufacturer Country/Area United Kingdom   
Product Code 72AYT99   
Importer's Product Description HERBAL CAT FOOD   
Refusal Date 20-Jan-2012   
FDA District CIN-DO   
Entry/doc/line/sfx AEK-0021215-5/1/1
FDA Sample Analysis No   
FDA Record of Private Lab Sample Analysis No   
Charge(s) Violation Code Section Charge Statement
DIETARY   403(j), 801(a)(3); MISBRANDING   The article purports to be or is represented for special dietary uses and its label does not appear to bear the nutritional information required by regulation.   
FALSE   403(a)(1), 801(a)(3); MISBRANDING   The labeling appears to be false and misleading in any particular.   
 


http://www.accessdata.fda.gov/scripts/importrefusals/ir_detail.cfm?EntryId=231-1235318-3&DocId=1&LineId=1&SfxId=

Manufacturer FEI 3005436047
Manufacturer Name Shandong Crown Soya Protein   
Manufacturer Address line 1 Guyun Economic Development Zone   
Manufacturer Address line 2 Shenxian County   
Manufacturer's City Liaocheng City   
Manufacturer Province/State Shandong   
Manufacturer Country/Area China   
Product Code 18EFT03   
Importer's Product Description SOYA PROTEIN ISOLATE    
Refusal Date 23-Jan-2012   
FDA District CHI-DO   
Entry/doc/line/sfx 231-1235318-3/1/1
FDA Sample Analysis No   
FDA Record of Private Lab Sample Analysis Yes   
Charge(s) Violation Code Section Charge Statement
MELAMINE   402(a)(2)(C)(i), 801(a)(3); ADULTERATION   The article appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409 [Adulteration, section 402(a)(2)(C)(i)].   
POISONOUS   402(a)(1), 801(a)(3); ADULTERATION   The article appears to contain a poisonous or deleterious substance which may render it injurious to health.   
UNFIT4FOOD   402(a)(3), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food [Adulteration, 402(a)(3)]   
 



http://www.accessdata.fda.gov/scripts/importrefusals/ir_detail.cfm?EntryId=231-1235318-3&DocId=1&LineId=2&SfxId=


Manufacturer FEI 3005436047
Manufacturer Name Shandong Crown Soya Protein   
Manufacturer Address line 1 Guyun Economic Development Zone   
Manufacturer Address line 2 Shenxian County   
Manufacturer's City Liaocheng City   
Manufacturer Province/State Shandong   
Manufacturer Country/Area China   
Product Code 18EFT03   
Importer's Product Description SOYA PROTEIN ISOLATE   
Refusal Date 23-Jan-2012   
FDA District CHI-DO   
Entry/doc/line/sfx 231-1235318-3/1/2
FDA Sample Analysis No   
FDA Record of Private Lab Sample Analysis Yes   
Charge(s) Violation Code Section Charge Statement
MELAMINE   402(a)(2)(C)(i), 801(a)(3); ADULTERATION   The article appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409 [Adulteration, section 402(a)(2)(C)(i)].   
POISONOUS   402(a)(1), 801(a)(3); ADULTERATION   The article appears to contain a poisonous or deleterious substance which may render it injurious to health.   
UNFIT4FOOD   402(a)(3), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food [Adulteration, 402(a)(3)]   
 
Logged
Pages: [1]
  Print  
 
Jump to:  

Copyright 2007 Itchmo.com: Read the latest cat, dog and pet news, pet food recall info, product reviews and more — updated daily.
Powered by SMF 1.1.21 | SMF © 2015, Simple Machines | Sitemap