Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration

 

New England District
1 Montvale Ave
Stoneham, MA 02180
Telephone: 781-596-7700
Fax: 781-596-7896

May 16, 2003
WARNING LETTER
VIA FEDEX

James Parker, Owner,
Vision Group
200 Lafayette Rd #5
North Hampton, NH 03862

Ref. No. NWE-17-03W

Dear Mr Parker:

On February 13-19 and March 14, 2003, we inspected your facility located at 200 Lafayette Rd #5, North Hampton, NH and collected labeling for your product Precision Vision. Review of your labeling indicates serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and Title 21, Code of Federal Regulations (21 CFR), Part 101 — Food Labeling. You can find the Act along with the food, drug and dietary supplement labeling regulations on the Internet through links on the FDA's web page at www.fda.gov. The following deviations were found.

Even if your product did not contain disease claims in its labeling that cause it to be a drug, it would still be misbranded under Section 403(q)(5)(F) of the Act in that the label fails to bear nutrition labeling as required under 21 CFR 101.36. The following are examples:

Other labeling deviations that misbrand your product under section 403 of the Act include the following:

The above violations are not meant to be an all-inclusive list of deficiencies for your products. It is your responsibility to assure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should review the labeling for all your products to assure compliance.

We request that you take prompt action to correct these violations. Failure to promptly correct violations may result in enforcement actions without further notice. These actions may include seizure and/or obtaining a court injunction against further marketing of your products.

Please notify this office in writing within fifteen (15) working days of receipt of this letter as to the specific steps you have taken to correct the stated violations. Copies of revised labeling should be submitted. You should also include an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be implemented.

Your reply should be sent to the attention of Bruce R. Ota, Compliance Officer, at the above address.

Gail T. Costello
District Director

This page was posted on July 31, 2005.

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