Inspections, Compliance, Enforcement, and Criminal Investigations
Hinsdale Farms, Ltd.
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
300 River Place
Detroit, MI 48207
July 24, 2009
RETURN RECEIPT REQUESTED
Hinsdale Farms, Ltd.
605 Kesco Drive
Bristol, IN 46507-8980
Dear Mr. Smith:
On March 6 - 26, 2009 and May 9 – 20, 2009 the Food and Drug Administration (FDA) conducted inspections of your ready-to-eat (RTE) vegetable corn dog manufacturing facility located at 605 Kesco Drive, Bristol, IN 46507-8980. We found that you have significant deviations from the current Good Manufacturing Practice (cGMP) regulations for food manufacturers (Title 21, Code of Federal Regulations (CFR), Part 110). These violations cause the foods manufactured at 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 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.
The following insanitary conditions were revealed during the March 2009 and May 2009 inspections:
Failure to maintain buildings, fixtures and physical facilities in a sanitary condition and in repair sufficient to prevent food from becoming adulterated as required by 21 CFR 110.35(a).
On March 24, 2009, we collected 90 environmental and product inline sub samples (sample INV 440401) from the Processing/Fry Room and Packaging Room, which are post-cook (post-lethality) areas of your manufacturing facility. These sub samples were collected post-sanitization and pre-production and from areas where fully cooked, ready-to-eat finished product is exposed. Eight (8) of the 90 environmental sub samples collected were analyzed and confirmed positive for Listeria monocytogenes. On April 9, 2009 we called your firm to advise you that our testing isolated Listeria monocytogenes from the following locations:
- Processing/Fry Room, sub 1A: Gaps in the floor around the drain directly under conveyor belt between fryer number 1 and 3
- Processing/Fry Room, sub 17A: Grate ledge of drain located near fryer number 4
- Processing/Fry Room, sub 19A: Gaps in the floor near drain in front of fryer number 1, underneath the conveyor belt
- Processing/Fry Room, sub 24A: Circular drain hole and cover located after fryer number 1 and leading to the freezer
- Processing/Fry Room, sub 39A: Second of eight holes on cement floor surface, closest to chute leading to the spiral freezer
- Processing/Fry Room, sub 40A: Third of eight holes on cement floor surface, closest to chute leading to the spiral freezer
- Processing/Fry Room, sub 43A: Eighth hole on cement floor surface, approximately seven feet from metal chute leading to the spiral freezer
- Packaging Room, sub 79A: Drain with removed cover within approximately two feet of filling on packaging line 3
After the March 2009 inspection, you implemented a test and hold program for your vegetable corn dogs. Between the March 2009 and May 2009 FDA inspections, you manufactured 12 lots of vegetable corn dogs. Your records document that two (2) of the 12 lots tested positive for Listeria monocytogenes and three (3) environmental samples tested positive for Listeria monocytogenes. Specifically:
On April 8, 2009, your firm manufactured your American Original Veggie Corn Dog. Your laboratory analysis of this finished product, Product ID 975000, Sample ID 904299-22, confirmed positive for Listeria monocytogenes.
On April 14, 2009 your firm conducted environmental sampling which confirmed Listeria monocytogenes in three locations: “Inside Exit of SS Duct From Mini Spiral”, “Inside Exit of Overflow Chute From Mini” and “Under Removed Kemlite”.
On April 25, 2009 your firm manufactured your American Original Veggie Corn Dog. Your laboratory analysis of this finished product, Sample Code 21, Laboratory ID 316541064, was confirmed positive for Listeria monocytogenes.
We acknowledge receiving your April 15, 2009 response to the FDA-483, Inspectional Observations. We have determined that your written response is inadequate to address the objectionable conditions because you have continued to find Listeria monocytogenes in the environment and in finished product. During the May 9 – 20, 2009 inspection, our investigators observed that your firm has implemented several corrective actions since the March 6 – 26, 2009 inspection. These corrective actions included excavating and replacing trough drains, installing concrete curbing, replacing pieces of manufacturing equipment, conducting in-depth sanitation of the entire facility, and revising sanitation standard operating procedures (SSOPs).
We have determined that your corrective actions are ineffective because your verification efforts (environmental and finished product sampling) have found Listeria monocytogenes in the manufacturing areas and in finished product.
We also acknowledge that the (b)(4) initiated a voluntary Class 2 recall of all (b)(4) veggie corn dogs during the May 2009 inspection. Additionally, you have represented that no FDA regulated product has been manufactured since May 2, 2009.
Listeria monocytogenes within your manufacturing facility presents an increased risk of pathogenic contamination to your food production operations and sanitation. Steps should be taken to immediately correct the violations outlined above and to further ensure that your current cleaning and sanitizing programs are effective.
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 your processing plant operates in compliance with applicable statutes enforced by the FDA. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure or injunction.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: LCDR Anastasia M. Piliafas-Brown, Compliance Officer, Detroit District Office, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions regarding any issues in this letter, please contact LCDR Anastasia M. Piliafas-Brown at 313-393-8270.
Joann M. Givens
Detroit District Office
Warning Letter Log