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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Keystone Food Products Inc 18-Dec-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: 215-507-4390


WARNING LETTER
08-PHI-04

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

December 18, 2007

William Corriere, CEO
Keystone Food Products, Inc.
3767 Hecktown Road
Easton, PA 18045-2350

Dear Mr. Corriere:

An inspection of your snack food manufacturing plant, located at 3767 Hecktown Road, Easton, PA, conducted by the Food and Drug Administration (FDA) on April 25-26, 2007, found significant deviations from the Current Good Manufacturing Practice (cGMP) regulations for food manufacturers (Title 21, Code of Federal Regulations, Part 110). These violations cause the foods manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and FDA's regulations through links in FDA's home page at www.fda.gov.

Specifically, our inspection of your facility revealed the following sanitation deviations:

(1) In order to comply with 21 CFR 110.80(b)(1), equipment shall be maintained in an acceptable condition through appropriate cleaning and sanitizing; as necessary.

Our investigator observed the failure of your firm to properly clean your manufacturing equipment located in the "Baking Room." Food particles were observed on the vibrator belt leading into the packaging area on line [redacted], on the vibrating belt incline, and several areas in another vibrating belt which leads to packaging lines [redacted] and [redacted]. This equipment is used to manufacture both products containing dairy ingredients and those not containing dairy ingredients.

(2) In order to comply with 21 CFR 110.40(a), all plant equipment shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. Our investigator observed that your [redacted] blades, which are used to mix and suspend ingredients, have rough welded areas which could trap food residues and cross contaminate product.

(3) In order to comply with 21 CFR 110.35(d), all food contact surfaces shall be cleaned as frequently as necessa ry to protect against contamination of food.

Our FDA investigator was informed that [redacted] foam cleaner is used to clean and sanitize between products; however, a review of your SOP #0913 states the following under the EQUIPMENT section: "A [redacted] only are to be used on product contact surfaces."

At the conclusion of the inspection you were presented with form FDA-483 (Inspectional Observations form) listing these deviations from the regulations. You informed our investigator that you would take appropriate corrective action. Also, during the inspection, FDA provided your firm with information regarding a consumer complaint regarding a product that your firm manufactured for the own-label distributor [redacted]. The complainant's child suffered an anaphylactic reaction immediately after consuming two bites of the product, [redacted] with [redacted] and [redacted] with the production code [redacted]. The child has a documented allergy to milk. Your investigation into the manufacturing of this product revealed that it was produced the day after your firm manufactured another product [redacted] which contains dairy ingredients.

FDA analysis found the presence of milk in the sample FDA collected from the complainant of [redacted] with the same production code "[redacted]". Your firm also faxed our investigator a copy of analytical results obtained from your firm's retention sample of [redacted] from the same production lot, which indicated greater than [redacted] of milk present in your product.

While there is precautionary labeling on [redacted] which states "This product is manufactured in a facility that produces dairy products", precautionary labeling must not be used in lieu of adherence to good manufacturing practices. Manufacturers are responsible for ensuring that their products are not adulterated as a result of undeclared allergens.

When allergens that are not specifically formulated in a food are identified as likely to occur in the food because of manufacturing practices, the manufacturer should identify and implement controls to reduce or prevent allergen cross contact. Examples of preventive measures include production scheduling and dedicated equipment for production runs of products for which cross contact is a concern, and proper cleaning.

This letter may not list all the, deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the, Act, and the cGMP regulations (21 CFR Part 1.10), and other FDA regulations implementing the Act and ensuring that all of your products are labeled in compliance with the laws and regulations enforced by FDA.

You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to, seizure or injunction.

Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific things that you are doing to correct these deviations. You may wish to include in your response documentation that would be useful in assisting us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.

Your response should be sent to Lynn S. Bonner, Compliance Officer, at the address noted above. If you have any questions with regard to this letter, Ms. Bonner can be reached at 215-717-3074 or Lynn.Bonner@fda.hhs.gov.

Sincerely,

Thomas D. Gardine
District Director
Philadelphia District

cc: Edward Gonzalez, President
Keystone Food Products, Inc.
3767 Hecktown Road
Easton, PA 18045-2350