Department of Health and Human Services
Public Health Service
240 Hennepin Ave
May 28, 1998
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Arnold M. Suresky, President
Shara Laboratories, Inc.
248 E Town Line Rd
Wautoma, WI 54982
Ref. No. MIN 98-31
Dear Mr Suresky:
The Food and Drug Administration (FDA) conducted an inspection of your nutrient supplement manufacturing facility in Wautoma, WI, on February 2, 1998. Five samples were collected for nutrient analysis by FDA laboratories and were identified by sample numbers 98-561-985/989.
Sample 98-561-985 is a [redacted] Calcium, Magnesium and Zinc nutrient supplement, Lot no. 7348. Analysis of this sample reveals serious violations of the Federal Food, Drug and Cosmetic Act (the Act):
- Calcium levels are less than 50% of that claimed on the label.
- Magnesium levels are less than 23% of that claimed on the label.
These laboratory findings cause the [redacted] Calcium, Magnesium and Zinc supplement to be adulterated according to Section 402(b)(1) of the Act in that a food shall be deemed to be adulterated if any valuable constituent has been in whole or in part omitted or abstracted therefkom. This [redacted] Calcium, Magnesium and Zinc supplement is also misbranded according to Section 403(a) of the Act in that a food shall be deemed to be misbranded if its labeling is false or misleading in any particular.
Review of your file indicates the only correspondence has been from FDA to you with a copy of the post-inspectional Establishment Inspection Report.
You should take prompt action to correct these violations. Failure to promptly correct these violations of the Act may result in regulatory action being init;at;d by FDA without further notice and may include product seizure and/or injunction. Please notify this office in writing within 15 working days of the receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations with your entire product line. If corrective action cannot be completed within 15 working days, state the reason and the time within which the corrections will be completed.
Your reply and any questions you may have should be directed to Compliance Officer Thomas P. Nelson at the address indicated on the letterhead.
James A. Rahto
This page was posted on August 20, 2006.