On March 4, 2010, the security guards at the entrance to
SM Makati at Ayala Center, Makati, didn't inspect/subject my luggage to scanning.
Said luggage was large enough to contain deadly weapons.
The guard, at the entrance to SM Supermarket at SM
Building at Ayala Center, Makati, didn't inspect my
luggage/subject it to scanning.Said luggage was large enough
to contain deadly weapons.The guard at entrance to
SM Appliances at SM Building, Makati, didn't inspect
my luggage/subject my luggage to scanning. Said luggage
was large enough to contain deadly weapons.
On March 4, 2010, when I went to the Chow King restaurant, at SM Makati building at
Ayala Center, Makati, employee,identified as "Julie Ann" didn't have
the required health certificate attached to the upper left
of the clothing she was wearing. Also, while I was at said restaurant,
there was no visible required express lane for senior citizens and required
sign regarding privileges for senior citizens, contrary to implementing
rules and regulations of the Expanded Senior Citizens Act of 2003.
web sites with useful free information:
http://www.healthdialog.com/Main/default
http://repairpal.com/
http://www.steves-digicams.com/knowledge-center/
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U.S. Food and Drug Administration warning letters
http://www.fda.gov./ICECI/EnforcementActions/WarningLetters/default.htm#recent
*
Recently Posted Warning Letters
Posted on March 03, 2010
Letter Issue Date Company Name Issuing Office Subject Close Out Date
February 23, 2010 Pom Wonderful25 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Dreyer's Ice Cream Inc.26 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Sunsweet Growers Inc.27 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Spectrum Organic Products, Inc.28 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Pbm Products, LLC29 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Redco Foods, Inc.30 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 First Juice31 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Beech-Nut Nutrition Corporation32 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Diamond Food Inc.33 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Ken's Foods, Inc.34 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Fleminger Inc35 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Gorton's, Inc.36 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Pompeian, Inc.37 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Guangzhou Yong Want Foods Ltd38 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Gerber Products Co39 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
February 22, 2010 Schwan's Consumer Brands40 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
December 04, 2009 Nestle USA41 Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded Not Issued *
Posted on March 02, 2010
Letter Issue Date Company Name Issuing Office Subject Close Out Date
February 24, 2010 Centrix Pharmaceutical Inc42 New Orleans District Office New Drug/Adulterated Not Issued *
February 23, 2010 HMI Industrries, Inc.43 Cincinnati District Office CGMP/QSR/Adulterated/Misbranded Not Issued *
February 18, 2010 Stardust Dairy, LLC44 Cincinnati District Office Animal Sale for Slaughter as Food/Adulterated Not Issued *
February 18, 2010 Vertical Pharmaceuticals, Inc.45 New Jersey District Office Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Body Tools46 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 King Cone International47 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Amasha48 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Indian Mountain Center49 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Bobalee Originals Manufacturing50 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 International Ear Candle, LLC51 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Home Remedies Solutions52 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Harmony Cone53 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 A.J.'s Candles, Inc54 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Wholistic Health Solutions55 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Health, Wealth, & Happiness56 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 White Egret, Inc.57 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Wally's Natural Products, Inc.58 San Francisco District Office Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Brennan And Mccoy59 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 17, 2010 Herbs, Heirlooms and Homebrew60 Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 16, 2010 La Mexicana, Inc.61 Seattle District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions Not Issued *
February 16, 2010 Biological Controls62 New Jersey District Office CGMP/QSR/Adulterated/Misbranded Not Issued *
February 16, 2010 Crestview Calves, Inc.63 Seattle District Office Animal Sale for Slaughter as Food/Adulterated Not Issued *
February 16, 2010 Gourmet Express Marketing, Inc.64 Chicago District Office Seafood HACCP/CGMP/Misbranded Not Issued *
February 11, 2010 Rangen Inc65 Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded Not Issued *
February 08, 2010 Magna Pharmaceuticals, Inc66 Cincinnati District Office Labeling/False & Misleading Claims/New Drug/Misbranded Not Issued *
February 08, 2010 Poly Pharmaceuticals, Inc67 New Orleans District Office New Drug/Adulterated Not Issued *
January 13, 2010 Innovative Beverage Groups Holdings, Inc68 Dallas District Office Labeling/Adulterated Not Issued *
October 28, 2009 Juices International69 New York District Office CGMP for Foods/Juice HACCP/Adulterated Not Issued *
October 05, 2009 Mystical One LLC70 New York District Office CGMP for Foods/Juice HACCP/Adulterated Not Issued *
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Page Last Updated: 01/28/2010
_____________________________________________________________________________________
U.S. Food and Drug Administration warning letter to Gerber
http://www.fda.gov./ICECI/EnforcementActions/WarningLetters/ucm202821.htm
Gerber Products Co
Department of Health and Human Services logoDepartment of Health and Human Services
Public Health Service
Food and Drug Administration
College Park, MD 20740
FEB 22 2010
WARNING LETTER
VIA OVERNIGHT MAIL
Mr. Kurt Schmidt
Business Head
Nestle Nutrition
North American Headquarters
12 Vreeland Road
Florham Park, NJ 07932
Re: CFSAN-OC-10-09
Dear Mr. Schmidt:
The Food and Drug Administration (FDA) has reviewed the labels for the products in your Gerber Graduates Fruit Puffs line and the label of your Gerber 2nd Foods Carrots product, as well the labeling for these products on your website, www.gerber.com. Based on our review, we have concluded that these products are in violation of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and regulations on FDA's website at www.fda.gov.
The products in your Gerber Graduates Fruit Puffs line are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because their labeling includes unauthorized nutrient content claims. Except for claims regarding the percentage of a vitamin or mineral for which there is an established Reference Daily Intake (RDI), a nutrient content claim may not be made for a food intended specifically for use by infants and children less than 2 years of age unless the claims is specifically provided for in parts 101, 105, or 107 of FDA regulations. 21 CFR 101.13(b)(3). Your Graduates Fruit Puffs products are specifically intended for infants and children under age 2. For example, the labeling indicates that the products are designed for the "crawler" stage of a child's life. The labeling for these products includes nutrient content claims such as "good source of iron, zinc, and vitamin E for infants and toddlers." The circumstances under which "good source" claims are permitted are defined in 21 CFR 101.54. That regulation does not allow such claims for foods intended specifically for infants and children under 2.
Your 2nd Foods Carrots product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because its labeling includes unauthorized nutrient content claims. This product is also intended specifically for infants and children under the age of two. For example, its labeling states that the product is appropriate for a "sitter," and sitting is a developmental milestone that generally occurs by the age of one. The 2nd Foods Carrots product label bears the nutrient content claim "healthy" as part of the statement "As Healthy as Fresh," and nutrient content claims such as "Excellent Source ... of Vitamin A" and "No Added Sugar." These circumstances under which such claims are permitted are defined in 21 CFR 101.65(d), 21 CFR 101.54(b), and 21 CFR 101.60(c). However, these regulations do not allow the claim for products specifically intended for children under two years of age.
The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that your firm and all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory actions without further notice, such as seizure and/or injunction.
You should take prompt action to correct these violations. Please respond to this letter within 15 days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
You should direct your written reply to Kathleen M. Lewis, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835.
Sincerely,
/S/
Roberta F. Wagner
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
cc: FDA New Jersey District
FDA Detroit District
Mr. Mark E. Shipley
Plant Manager
Gerber Products Company
405 E. State Street
Fremont, MI 49412
_____________________________________________________________________________________________________________________________________________________________________
U.S. Food and Drug Administration warning letter to Nestle
http://www.fda.gov./ICECI/EnforcementActions/WarningLetters/ucm194122.htm
Nestle USA, 12/4/09
Department of Health and Human Services' logoDepartment of Health and Human Services
Public Health Service
Food and Drug Administration
College Park, MD 20740
DEC 04 2009
Brad Alford, Chairman and CEO
Nestle U.S.A.
800 North Brand Boulevard
Glendale, CA 91203
WARNING LETTER
Re: CFSAN-OC-10-05
Dear Mr. Alford:
The Food and Drug Administration (FDA) has reviewed the labeling for several Nestle Juicy Juice products: Juicy Juice Brain Development Fruit Juice Beverage (Apple), Juicy Juice All-Natural 100% Juice Orange Tangerine, and Juicy Juice All-Natural 100% Juice Grape. Based on our review, we have concluded that these products are misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 343] because their labeling deviates from the requirements of the Act and FDA regulations at Title 21 of the Code of Federal Regulations.
Your Juicy Juice Brain Development Fruit Juice Beverage product is misbranded within the meaning of section 403(r) of the Act [21 USC 343(r)] because its labeling includes unauthorized nutrient content claims. Except for statements that describe the percentage of a vitamin or mineral in relation to a Reference Daily Intake (RDI), a nutrient content claim cannot be made for a food intended for use by infants and children less than 2 years of age unless the claim is specifically provided for in parts 101, 105, or 107 of FDA regulations. 21 CFR 101.13(b)(3). This product is marketed specifically for children under two years of age, as indicated by the claim "Helps support brain development***In children under two years old," which appears on the product label. The label also bears the nutrient content claim "no sugar added." The circumstances under which a "no sugar added" claim is permitted are defined in 21 CFR 101.60(c). That regulation does not allow the claim for conventional food products intended for use in children under age 2. 21 CFR 101.60(c)(4). Therefore, the claim "no sugar added" misbrands your product.
On October 30, 2009. we also reviewed your website, http://www.juicyjuice.com. the address of which is listed on the Juicy Juice Brain Development Fruit Juice Beverage label. The labeling found on your website makes an additional unauthorized nutrient content claim, which
further misbrands the product. The website claims that Juicy Juice Brain Development Fruit Juice Beverage is "naturally lower in sugar." As noted above, except for statements that describe the percentage of a vitamin or mineral in relation to an RDI, no nutrient content claims can be made for a food intended specifically for use by infants and children less than 2 years of age unless specifically permitted by FDA regulations. 21 CFR 101.13(b)(3). The circumstances under which a "lower in sugar" claim is permitted are defined in 21 CFR 101.60(c)(5). That regulation does not allow the use of the claim for food products intended for use in children under age 2.
Additionally, we have reviewed the labeling of your Nestle Juicy Juice All Natural 100% Juice Orange Tangerine and Nestle Juicy Juice All Natural 100% Juice Grape products. These products are misbranded under section 403(a)(1) of the Act [21 USC 343(a)(1)] because their labels are misleading. The label of the Orange Tangerine product is designed to imply that the product is 100% orange/tangerine juice, and the label of the Grape product is designed to imply that product is 100% grape juice. The principal display panels identify the products as "Orange Tangerine" and "Grape," respectively, in large, bold lettering outlined in black; however, neither orange/tangerine juice nor grape juice is the predominant juice in the products.The statements "All Natural-100% Juice" in close proximity to the words "Orange Tangerine"or "Grape" and vignettes of oranges or grapes also may lead consumers to believe that the products are 100% orange/tangerine juice or 100% grape juice when, in fact, they are not. The separate statement at the base of the respective principal display panels, "Flavored juice blend from concentrate with other natural flavors & added ingredients," appears in a smaller font and white print on a colored background. The manner in which the latter statement is presented makes it less conspicuous and prominent than the other label statements and vignettes and therefore less likely to be read or understood by consumers at the time of purchase.
The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory actions without further notice, such as seizure and/or injunction.
You should take prompt action to correct these violations. Please respond to this letter within 15 days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
You should direct your written reply to Quyen Tien, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Brooch Parkway, Office of Compliance (HFS608), Division of Enforcement, College Park, Maryland 20740-3835.
Sincerely,
/S/
Roberta F. Wagner
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
cc: FDA Los Angeles District Office
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