Hawks Nuts, Inc. 11/20/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
November 20, 2012
Hawks Nuts, Inc.
4713 North Hale Avenue
Tampa, Florida 33614
Dear Ms. Hawks:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your low-acid canned food manufacturing facility, Hawk’s Nuts, Inc., located at 4713 North Hale Avenue, Tampa, Florida from July 17, 2012, through July 27, 2012. During the inspection we found that your firm manufactures canned, ready to eat (RTE) boiled peanuts. During the inspection, our investigators observed serious deviations from the Low-Acid Canned Food regulations, Title 21, Code of Federal Regulations, Parts 108 and 113 (21 CFR 108 and 113) and the Good Manufacturing Practices regulations, 21 CFR 110.
As a manufacturer of low-acid canned food products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of low-acid canned food products. These regulations are described in 21 CFR 108, Emergency Permit Control and 21 CFR 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers. The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act, Emergency Permit Control [21 United States Code (U.S.C.) § 344]. A temporary emergency permit may be required for low-acid canned foods whenever a processor has failed to fulfill the mandatory requirements of 21 CFR 108 and 113.
As such, the conditions in your facility and the practices of you and your firm’s employees cause the ready-to-eat (RTE) food products manufactured by your firm (canned, RTE boiled peanuts) to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth.
Furthermore, during the inspection, our investigators collected labels of your food products. Our review of the labels and other evidence collected during the inspection indicate that your firm’s 60 oz. cans of Original Cajun Jumbo Boiled Peanuts, Original Regular Boiled Peanuts, Jalapeno Boiled Peanuts and Hawks Caramel Corn products are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343] and its implementing regulations in 21 CFR Part 101. You may find the Act and its implementing regulations through links on FDA’s website at http://www.fda.gov
This inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection.
Your significant violations are as follows:
1. Contrary to established venting requirements, your firm’s process timing began before the retort was properly vented and the processing temperature was reached as required by 21 CFR 113.40(a)(12). Specifically, during inspection of your firm's canning of Cajun jumbo boiled peanuts in 603 x 700 cans (batch#12199R2B2) on 7/17/2012, the vent was observed to be completely closed following the retort operator's verbal statement and recording on the batch record that the venting period had commenced. Approximately 3 minutes into the venting cycle, the operator turned the valve lever approximately 20 degrees to partially open it, and it remained only partially open throughout the remainder of the vent cycle.
Additionally, there was no documented venting cycle information from the process authority that was made available for review during the inspection, and we were unable to determine if venting parameters were being conducted as intended in the scheduled process.
2. Failure to adjust the temperature-recording device such that it is in no event higher than the known accurate mercury-in-glass thermometer during the process time and to prevent the unauthorized changes to the temperature-recording device as required by 21 CFR 113.40(a)(2).
Your firm's scheduled process filed with FDA (SID 2003-08-08/001) for jumbo boiled peanuts in brine, 603x700 #10 cans (regular, Cajun, jalapeno), lists a process time of (b)(4) minutes at (b)(4) degrees Fahrenheit. Your firm's current operating parameter is (b)(4) minutes at (b)(4) degrees Fahrenheit for this product and container size. During review of your calibration records it was observed that the temperature-recording device was purposefully adjusted to read (b)(4) degrees Fahrenheit above the MIG thermometer. During observation of your firm's canning of Cajun jumbo boiled peanuts batch #12199R2B2 on 7/17/2012, it was observed that the temperature-recording device was documenting (b)(4) degrees Fahrenheit, while the MIG was noted at least once to be at (b)(4) degrees Fahrenheit.
Your firm’s August 13, 2012 response includes documentation of calibration of both the MIG and the temperature recorder chart. This corrective action will be verified during the next inspection to ensure that the MIG is not reading (b)(4) than the recorder chart at any time.
3. Your firm did not determine and record the initial temperature of the contents of a container to be processed with sufficient frequency to ensure the temperature was not (b)(4) than the minimum initial temperature stated in the filed scheduled process as required by 21 CFR 113.87(c).
Your firm's retort operator verbally stated on 7/17/2012, that the products’ initial temperature as documented on the batch log represents the initial retort temperature prior to commencing the come-up period. Your firm is currently not measuring any product temperatures to ensure that the initial product temperature of (b)(4) degrees F is being met as stated in your scheduled process for (SID 2003-08-08/001), jumbo boiled peanuts in brine, 603x700 #10 cans (regular, Cajun, jalapeno). We acknowledge the receipt of your “Batch Log” as part of your corrective actions in your firm’s response; however, it was blank and did not include actual recordings of production to implementation.
4. Your firm failed to measure and record the drain weight specified in the scheduled process at intervals of sufficient frequency to ensure that the weight of the product is within limits specified in the scheduled process as required by 21 CFR 113.40(a)(13)(i). Specifically, your firm's scheduled process filed with FDA (SID 2003-08-08/001) for jumbo boiled peanuts in brine, 603x700 #10 cans (regular, Cajun, jalapeno), lists a maximum drained weight of 65 oz. as a critical factor for this process. Your firm is currently only documenting one fill weight measurement per batch, and is not measuring the drained weight of the product after thermal processing has occurred. In addition, your firm is currently not monitoring additional critical factors of minimum free liquid at closing and drained weight/net weight ratio to ensure that the established limits are not exceeded. We acknowledge the receipt of your “Batch Log” as part of your corrective actions in your firm’s response; however, it was blank and did not include actual recordings of production to implementation.
5. Your firm failed to establish a system for product traffic control in the retort room to prevent unretorted product from bypassing the retort process as required by 21 CFR 113.87(b). Specifically, on 07/17/2012, our investigators observed retort baskets that had been thermally processed on the processing floor at the same time as other retort baskets containing unprocessed product. We acknowledge that your firm’s response indicates that you are currently using heat sensitive indicators on cans during the processing of all batches and that you are using colored retort baskets to prevent placement errors; however, the implementation of these corrective actions will be verified during the next inspection.
6. Your firm failed to prepare and maintain current procedures for products under your control and that you will ask your distributors to follow, including plans for effecting recalls of any products that may be injurious to health; for identifying, collecting, warehousing, and controlling the product; for determining the effectiveness of such recall; for notifying the FDA of any such recall; and for implementing such recall program, as required by 21 CFR 108.35(f).
Your firm has not established written recall procedures for any of the low acid canned food products which you manufacture, including jumbo boiled peanuts in 603x700 #10 cans. We acknowledge that your firm’s response included “#10 can production sheet” and “#10 can tracking sheet”; however, your response in incomplete in that you failed to submit a detailed plan you would follow during an actual recall
7. In order to comply with 21 CFR 110.35(c), no pests shall be allowed in any area of your food facility. Furthermore, effective measures shall be taken to protect against the contamination of food on the premises by pests.
Specifically, on 07/17/2012, at least 13 rodent excreta pellets (REPs) were observed in the retort processing area on a pallet of #10 cans intended for use in canning production.
The same or similar observations were noted in establishment inspections conducted in May 2009 and February 2010.
We have the additional concerns which were identified on the FDA 483 regarding compliance with 21 CFR 113.81(f). Critical factors identified in the scheduled process for the prevention of the growth of microorganism not destroyed by the thermal process are not controlled in a manner to ensure limits established are not exceeded. Specifically, your firm’s scheduled process filed with FDA (SID 2003-08-08/001 for Jumbo Boiled Peanuts in brine in 603X700 #10 cans (regular, Cajun, jalapeno)), lists additional critical factors for this process including minimum free liquid at closing and a drained weight/net weight ratio. Your firm is currently not monitoring for these critical factors to ensure that the established limits are not exceeded, including batches #12199R2B1 and #12199RB2 of Cajun Jumbo boiled peanuts that were observed being processed 7/17/2012.
Your firm has not obtained specifications from the can manufacturer and was unable to provide documentation to determine whether the measurements you observe during can tear down examinations are within acceptable limits. In addition, your firm is not measuring the tightness or thickness during your canned seam tear down evaluations as required by 21 CFR 113.60(a)(1)(i)(a). Your firm is also not monitoring and documenting the double seam characteristics at three different points approximately 120 degrees apart and excluding the side seam as required by 21 CFR 113.60(a)(1)(ii).
1. Your Hawks Caramel Corn product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the label for this product fails to declare the known major food allergen, milk, as specified by the Act.
Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines as “major food allergens” milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:
- The word “Contains,” followed by the name of the food source from which the major food allergen is derived, printed immediately after or adjacent to the list of ingredient, section 403 (w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or
- The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g. “(wheat)”), except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act, [21 U.S.C. 343(w)(1)(B)].
Specifically, your Hawks Caramel Corn product label reveals that the ingredient butter is used in the products manufacture; however the product labels fail to declare the presence of the major food allergen, milk.
2. Your 60 oz. cans of Original Cajun Jumbo Boiled Peanuts, Original Regular Jumbo Boiled Peanuts and Original Jalapeno Jumbo Boiled Peanut products are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(k)] because the products bear or contain “MSG” but do not declare the ingredient by its common or usual name. Monosodium glutamate used as an ingredient in food shall be declared by its common or usual name which is "monosodium glutamate" in accordance with 21 CFR 101.22(h)(5). This is a repeat violation by your firm.
3. Your 60 oz. cans of Original Cajun Jumbo Boiled Peanuts, Original Regular Jumbo Boiled Peanuts and Original Jalapeno Jumbo Boiled Peanuts are misbranded within the meaning of section 403(q)(1) of the Act [21 U.S.C. § 343(q)(1)] because the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Your products failed to bear a statement of the number of grams of Trans Fat in accordance with 21 CFR 101.9(c)(2)(ii). This is a repeat violation by your firm.
The above violations are not meant to be an all-inclusive list of deficiencies in your facility. It is your responsibility to assure that all of your products are in compliance with applicable laws and regulations. You should act quickly to correct the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure of your products and/or injunction of your firm.
In addition to the labeling deviations noted above, the Nutrition Facts panels for your labels do not comply with the regulation in 21 CFR 101.9(b) and (c). For example, the nutrients are not listed in the correct order; the labels do not bear the required footnote; the nutrients are not listed in the gram increments as required; and the serving size declaration does not include a common household measure.
You should respond in writing within 15 working days from your receipt of this letter. Your response should specify what you are doing to correct the violations referenced in this letter and include any documented evidence of corrective actions already accomplished. Proof of your corrections may include the following: copies of reports from your pest service contractor; photographs showing repairs, renovations, and clean-up on the interior and exterior of your facility; copies of new or revised processing and production forms (batch log forms) for your canned, RTE boiled peanuts; and examples of revised finished product labeling. If you cannot complete all corrections before you respond, please explain the reason for your delay and provide us with a timeframe for the correction of any outstanding violations.
Please send your response to the Food and Drug Administration, Attention: Carla A. Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issue in this letter, please contact Ms. Norris at (407) 475-4730.
Emma R. Singleton
Director, Florida District