Inspections, Compliance, Enforcement, and Criminal Investigations
Nestle S.A. 27-Nov-06
Department of Health and Human Services
Public Health Service
Minneapolis District Office
November 27, 2006
Refer to MIN 07-07
RETURN RECEIPT REQUESTED
Chairman & CEO
Avenue Nestle 55
Vevey, Switzerland 1800
Dear Mr. Brabeck:
An inspection of your facility located at 1200 Nestle Avenue, Eau Claire, Wisconsin, was conducted by an investigator from the Food and Drug Administration (FDA) on May 17, 18, 22-24, 2006. A sample of your Nestle® brand Good Start Infant Formula with Iron, 13 fluid ounces, was collected on May 26, 2006. Our analytical review of this product reveals that your Nestle® brand Good Start Infant Formula with Iron is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and the implementing regulations contained within Title 21, Code of Federal Regulations, Part 107 (21 CFR 107). You may find the Act and the CFR through links on FDA's home page at www.fda.gov.
FDA analyzed a sample of your Nestle® brand Good Start Infant Formula with Iron for nutrient content specific to the requirements for infant formula listed in 21 CFR 107.100(a). The analytical results show that the nutrient levels for calcium and phosphorus do not meet the minimum levels required in 21 CFR 107.100(a) and are less than what is declared on the label. Analysis reveals the calcium content per 100 Kilocalories is 58.2 mg (original analysis) and 58.6 mg (check analysis); the minimum requirement per 100 Kilocalories for calcium is 60 mg and the label declaration for calcium is 64 mg. Analysis reveals the phosphorus content per 100 Kilocalories is 28.9 mg (original analysis) and 29.4 mg (check analysis); the minimum requirement per 100 Kilocalories for phosphorus is 30 mg and the label declaration for phosphorus is 36 mg. Consequently, your product is adulterated under section 412(a)(1) of the Act [21 U.S.C. 350a(a)(1)] because the formula does not provide nutrients as required by section 412(i) of the Act [21 U.S.C. 350a(i)]. In addition, your product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)].
This letter is not meant to be an all-inclusive list of deficiencies that may exist in your product labeling. It is your responsibility as top management to ensure that your establishment is in compliance with all requirements of the federal regulations.
You should notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and injunction.
Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated on the letterhead.