Inspections, Compliance, Enforcement, and Criminal Investigations
Ian's Natural Foods, Inc 12/10/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District
VIA United Parcel Service
December 10, 2010
Mr. Terrence P. Dalton
Ian’s Natural Foods, Inc.
190 Fountain St.
Framingham, MA 01702
Dear Mr. Dalton:
On May 7 – 17, 2010, June 28 – August 2, 2010, and September 1 – 21, 2010, the Food and Drug Administration (FDA) inspected your food manufacturing facility located at 190 Fountain St., Framingham, Massachusetts. On May 13, 2010, FDA collected a sample (number 594444) of finished frozen food product, Ian’s Egg & Maple Cheddar Wafflewich Wheat Free/Gluten Free Breakfast Sandwich, processed at your facility. Laboratory analyses confirmed the presence of Listeria monocytogenes, (L. monocytogenes), a human pathogen. These findings render your frozen food product to be adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(1)]. In addition, we found that you have significant violations of the Current Good Manufacturing Practice (CGMP) regulations for food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These violations cause the foods manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of 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 http://www.fda.gov.
L. monocytogenes is a pathogenic bacterium that can contaminate foods, resulting in a mild illness called listerial gastroenteritis or a severe, sometimes life-threatening, illness called invasive listeriosis. Immune-compromised individuals and unborn fetuses are particularly susceptible to listeriosis. It is essential that you identify all areas of your facility where L. monocytogenes is able to grow and survive (niche areas) and take such corrective actions as necessary to control the organism. FDA recommends that your sanitation controls include effective environmental monitoring programs designed to identify and eliminate and/or control pathogens such as L. monocytogenes in and on surfaces and areas in the facility where contamination could result in food product contamination. We acknowledge that the products associated with the positive L. monocytogenes finding were voluntarily destroyed. However, the presence of L. monocytogenes in your finished product may indicate colonization in other areas of your facility. L. monocytogenes differs from most other foodborne pathogens because it is widely distributed, resistant to diverse environmental conditions, and grows under refrigeration conditions. You should institute immediate corrective actions including intensified cleaning and sanitizing operations, and further testing to ensure L. monocytogenes does not occur in finished product.
We received your response, dated October 21, 2010, identifying corrective actions taken at your facility. Your response does not include details of how you will reassess your current Listeria monitoring program. FDA recommends that you outline the steps you will take if swabbing or sample results reveal potential contamination in your facility or in your product, and when these results may prompt intensified cleaning and sanitizing operations and further testing. You verbally informed FDA on November 16, 2010, of your decision to discontinue the manufacturing of ready-to-eat products at your facility. We request that you provide written confirmation that this action was performed and identify the products that will be produced at your facility.
The September 2010 inspection also found the significant violations of FDA's CGMP requirements. As required by 21 CFR 110.10(b), you must take all reasonable precautions to ensure that persons working in direct contact with food, food contact surfaces and food packaging materials conform to hygienic practices. However, on September 2, 2010, an employee was observed moving between raw product, finished product, and washroom areas without washing or sanitizing their hands to protect against contamination with undesirable microorganisms. In addition, on September 3, 2010, an employee was observed filling the bread crumb repacking machine with bread crumbs in direct contact with his ungloved hand immediately after he was observed using that hand to climb a ladder to the top of the repacking machine. These violations are of particular concern due to the presence of L. monocytogenes in your finished product, as they may further distribute the bacterium and/or contaminate food products.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and applicable regulations. Failure to promptly correct these violations may result in legal action without further notice including, but not limited to, seizure and injunction.
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.
Please send your reply to the Food and Drug Administration, Attention: Todd J. Maushart, Compliance Officer, One Montvale Ave, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Maushart at 781-596-7844.
Mutahar S. Shamsi
New England District