• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Svenhard's Swedish Bakery 28-Feb-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

San Francisco District

1431 Harbor Bay Parkway

Alameda, CA 94502-7070

Telephone: 510-337-6700

VIA FEDERAL EXPRESS

Our Reference: 3003455128

February 28, 2002

WARNING LETTER

Ronny Svenhard, President

Svenhard? s Swedish Bakery

70 1 Industrial Drive

Exeter, California 93221

On October 9 and 19, 2001, the U.S. Food and Drug Administration (FDA) conducted an

inspection of your firm located at 701 Industrial Drive, Exeter, California. During the

inspection we found that your apple struedel is misbranded under Section 403 of the

Federal Food, Drug, and Cosmetic Act (the Act).

The labels for Svenhard® SWEDISH BAKERY brand Apple Struedel do not declare

the presence of sulfites. Analysis of the product found undeclared sulfites, as sulfur

dioxide, as follows:

Analysis

Sample Number

Titrimetic Analysis

Gravimetric Analysis

Original

141680

13.0 ppm SO2

11.4 ppm SO2

Check

141680

21.7 ppm SO2

19.4 ppm SO2

Additional

141680

18.5 ppm SO2

17.5 ppm SO2

The product, Svenhard?s® SWEDISH BAKERY brand Apple Struedel, is misbranded

within the meaning of Section 403(k) of the Act in that the labels fail to declare the

sulfiting ingredient and to list its function in the product, in accordance with Title 21,

Code of Federal Regulations 101.100(a)(4), 101.22(j), and 101.4.

The above is not meant to be an all-inclusive list of deficiencies on your label. Other

label violations can subject the food to legal action. It is your responsibility to assure that

all of your products are labeled in compliance with all applicable statues enforced by

FDA.

You should take prompt measures to correct the violations. Failure to promptly correct

these violations may result in regulatory action without further notice. Such action

includes seizure and/or injunction.

You should notify this office in writing, within 15 working days of receipt of this letter,

of the specific steps you have taken to correct the noted violations. If corrective action

cannot be completed within 15 days, state the reasons for the delay and the time at which

the corrections will be completed.

Your reply should be directed to Ms. Harumi Kishida, Compliance Officer, U.S. Food

and Drug Administration, 1431 Harbor Bay Parkway, Alameda, California 94502-7070.

Sincerely,

Dennis K. Linsley

District Director

San Francisco District