• 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

Bay Valley Foods, LLC 31-Jul-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106

Telephone: 215-597-4390


WARNING LETTER
07-PHI-06

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

July 31, 2007

Mr. Gary Schoen, Senior Director Operations
Bay Valley Foods, LLC
1080 River Avenue
Pittsburgh, PA 15212

Dear Mr. Schoen:

We inspected your Acidified Food firm, located at 1075 Progress Street, Pittsburgh, PA 15212, between February 16, 2007 and March 13, 2007. We found that you have serious deviations from the Acidified Food regulations. Failure to comply with all of the requirements of 21 CFR 108.25 and the mandatory portions of part 114 constitutes a prima facie basis for the immediate application of the emergency permit control provisions of section 404 of, the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 344). In addition, such failure renders your Acidified Food adulterated within the meaning of Section 402(a)(4) of the Act (21 U.S.C. 342(a)(4)). Accordingly, your Earth's Best brand Apple Peach Barley Wholesome Breakfast baby food is adulterated within the meaning of section 402(a)(4) of the Act, in that is has been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health. You can find the Act and the Acidified Food regulations through links in FDA's home page at http://www.fda.gov.

In accordance with 21 CFR Part 114.80(a)(1), acidified foods must achieve and maintain a finished, equilibrium pH value of 4.6 or lower. Your acidified foods, as evidenced below, did not achieve and maintain, throughout the product shelf-life, the necessary pH value at or below 4.6.

During the above inspection, our investigators collected, and FDA analyzed samples of Earth's Best brand Apple Peach Barley Wholesome Breakfast baby food to determine whether the pH values were within the required guidelines of 4.6 or lower. A summary of the pH values is as follows:

•Sample #411293 - The pH values ranged between 4.55 and 4.92
•Sample #364369 - The pH values ranged between 4.56 and 4.65
•Sample #364370 - The pH values ranged between 5.27 and 5.37
•Sample #364371 - The pH values ranged between 6.00 and 5.50

We are in receipt, and acknowledge your March 28, 2007 response to the FDA-483. Concerning Observation l, you indicate that your firm is working with others to determine the cause of the elevated pH levels found in this product. At the time of inspection, Mr. Steier, Quality Control Manager, said that the firm would not produce Earth's Best Apple Peach Barley Wholesome Breakfast baby food and would hold the production run of such food made on 12/7/06 until the cause of the increased pH is found. FDA met with you on April 9, 2007 at which time the firm had not determined the cause of the product defect. Section 114.80(a)(1) requires that acidified foods shall be so manufactured, processed and packaged that a finished equilibrium pH value of 4.6 or lower is achieved within the time designated in the scheduled process and maintained in all finished foods.

Your responses to Observations 2-8 appear to be satisfactory. We will verify those corrective actions during our next scheduled inspection.

The above violations are not, meant to be an all-inclusive list of deficiencies in your plant. Other violations can subject the food to legal action. It is your responsibility to assure that all of your products are in compliance with applicable statutes enforced by the FDA.

We request that you respond to this letter in writing, within fifteen (15) working days of receipt of this letter. Your response should include the specific steps you have taken to correct the deviations. If you cannot complete all of the corrections within 15 working days, state the reason for the delay and the time within which corrections will be completed.

Your response should be directed to Ms. Robin M. Rivers, Compliance Officer, U.S. Food and Drug Administration, U.S. Customhouse, 2nd & Chestnut Streets, Room 900, Philadelphia, PA 19106. If you have any questions, please do not hesitate to contact Ms. Rivers at: (215)717-3076.

Sincerely,

/S/

Thomas D. Gardine
District Director
Philadelphia District Office

Enclosures
Form FDA 483 dated 3/13/07

cc: D. Joe Coning, President
Bay Valley Foods, LLC
1080 River Avenue
Pittsburgh, PA 15212

George Jurkovich, Senior Vice-President of Operations
Bay Valley Foods, LLC
1080 River Avenue
Pittsburgh, PA 15212

Pennsylvania State Department of Agriculture
Bureau of Foods and Chemistry
2301 North Cameron Street
Harrisburg, PA 17120-9408
Attn: Sheri Morris