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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Staples, Incorporated 3/7/12

  

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

Public Health Service
Food and Drug Administration
 San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700

WARNING LETTER

VIA UPS

March 07, 2012

Ronald L. Sargent, Chief Executive Officer
Staples, Incorporated
500 Staples Drive
Framingham, MA 01702

Dear Mr. Sargent:

The Food and Drug Administration (FDA) conducted an inspection of your facility located at 4510 Alitalia Avenue, Stockton, CA on October 20-November 3, 2011. During our inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). These violations cause the food products stored in your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)] in that the foods have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. The inspection also revealed that the products stored in your facility are adulterated per Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(3)] in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or are otherwise unfit for food. You can find the Act and the FDA regulations through links in FDA's homepage at www.fda.gov.

Your significant violations are as follows:

1. As required by 21 CFR 110.35(c), you must not allow pests in any area of a food plant. Effective measures must be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. However:

• Rodent excreta pellets (REP's) in numbers from 3-20 pellets were directly on, or in close vicinity to, multiple packages of at least 11 different food products, including various brands of candies, crackers, creamers, pistachios, ramen noodles, and bottled water, located in all areas of your warehouse.

• 23 out of 39 rodent traps, located along the inside perimeter of your warehouse contained one or more dead and decaying rodents; a hole roughly 4" x 5" in size located at the base of the north east wall of the warehouse contained a dead and decaying rodent.

• At least 4 apparent rodent excreta pellets were observed in the collection tray of a water cooler dispenser located at the south end of your warehouse; at least 20 apparent rodent excreta pellets were observed on top of boxes located at the north east end of the warehouse.

• Rodent gnawed holes ranging from "¼"  x ½" to 2" x 3" in diameter were seen directly on individual packages of at least I 0 different food products, including various brands of candies, crackers, creamers, pistachios, ramen noodles, and bottled water, located in all areas of your warehouse;

• Lab analysis confirmed rodent gnawed peanut butter and cheese sandwich crackers.

2. As required by 21 CFR 1100.20(b)(7), you must provide where necessary adequate screening or other protection against pests. However, our investigators observed the following during the inspection:

• At least 24 exterior leading doors were observed in the closed position in the north, east, southwest, and west side of your facility with gaps greater than  ½to 1" in diameter at the base of each door;

• Four(4) roll up exterior doors at the north and south walls of the warehouse were observed left open and employees were not actively moving product through these doors during the inspection.

We acknowledge that your firm voluntarily destroyed food products due to rodent adulteration under FDA supervision on October 21, 24, and 28, 2011, and that you have repaired six (6) roll-up doors.

We also acknowledge receipt of your firm's written response dated February 21, 2012 to the FDA-483, Inspectional Observations, issued to you at the close of the inspection. However, we were unable to properly evaluate your response since you did not provide any documentation of your implemented corrections; for instance, you did not submit photographs of the improvements made to the building, invoices of any new equipment or materials purchased, site map indicating the placement of rodent traps, pest control records indicating when pest control was performed and what was observed, and Staples Inventory Control department records indicating inspections, damage observed, and product removal and destruction. Your response further indicates that the presence of rodents is still evident in your facility; therefore you have not addressed how your actions will prevent future violations or adequately address the source of rodent infestation in your facility.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your written response should be directed to:

Darlene B. Almogela
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94502

Refer to the Unique Identification Number (CMS case 268158) when replying.

If you have any questions about the content of this letter please contact Ms. Aleta T. Flores, Compliance Officer at (510) 337-6821.

This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's facility. you should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.

Sincerely,

/s/

Barbara J. Cassens
District Director