Silva Foods Of Kansas City 7/12/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
11630 West 80th Street
Lenexa, Kansas 66214-3340
Telephone: (913) 752-2100
July 12, 2012
RETURN RECEIPT REQUESTED
Ref. KAN 2012-10
Robert F. Fernandez, Co-Owner
Silva Foods of Kansas City, Inc.
2540 West 47th Avenue
Kansas City, Kansas 66103
Dear Mr. Fernandez:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food processing facility located at 2540 W. 47th Avenue, Kansas City, KS 66103, between the following dates: May 22, 2012 and May 29, 2012. The inspection determined your facility produced acidified foods and revealed you have significant deviations from the requirements of the Acidified Food regulations described in Title 21, Code of Federal Regulations (CFR), Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR 114).
These significant deviations caused your acidified food products 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 have been prepared, packed, or held under unsanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath. The Act and regulations can be found on FDA’s webpage at www.fda.gov
As an acidified food processor, you are required to comply with the Act, and regulations relating to the processing of acidified foods and current good manufacturing practices. The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act [21 U.S.C. § 344]. A temporary emergency permit may be required for acidified foods whenever a processor fails to fulfill the mandatory requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements within 21 CFR Part 114.
The investigators discussed observations on the form FDA-483, Inspectional Observations, when it was issued to you on May 29, 2012. We noted the following serious violations:
1. As a commercial processor, your firm must register and file with FDA not later than 10 days after first engaging in the manufacture, processing or packing of acidified foods. The following products, which your firm manufactured using your firm’s salsa picante recipe (we note you add a small amount of jalapeno peppers to the basic recipe to produce the hot versions), have been determined to be acidified foods, namely Silva’s Mild Salsa,15 oz, Silva’s Hot Salsa, 15 oz Silva’s Mild Chunky Salsa, 31 oz and Silva’s Hot Chunky Salsa, 31 oz bottled in glass jars. However, your firm has not registered with FDA as an acidified foods manufacturer in accordance with the requirements of 21 CFR 108.25(c)(1).
2. As a commercial processor engaged in the processing of acidified foods, you must, no later than 60 days after registration and prior to the packing of a new product, provide FDA information as to the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). However, our inspection revealed you failed to file a scheduled process with FDA for the following products manufactured using your firm’s salsa picante recipe which have been determined to be acidified foods, namely Silva’s Mild Salsa,15 oz, Silva’s Hot Salsa, 15 oz Silva’s Mild Chunky Salsa, 31 oz and Silva’s Hot Chunky Salsa, 31 oz bottled in glass jars.
Your firm is responsible for determining which regulations apply to the products that you manufacture, including whether any of these products are considered to be acidified foods, as defined in 21 CFR 114.3(b), subject to the applicable provisions of 21 CFR parts 108 and 114. Accordingly, your firm should determine or have determined for you whether any additional products that you manufacture are acidified foods, and comply with the applicable requirements of 21 CFR 108 and 114 including registration and process filing for those products that are determined to be acidified foods.
3. You failed to establish scheduled processes of your acidified foods in accordance with 21 CFR 114.83. Specifically, you do not have scheduled processes established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods, as required by 21 CFR 114.83 for your firm’s Silva’s Mild Salsa,15 oz, Silva’s Hot Salsa, 15 oz Silva’s Mild Chunky Salsa, 31 oz and Silva’s Hot Chunky Salsa, 31 oz bottled in glass jars.
Scheduled process information for acidified or low-acid canned foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods,” available at: http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/
4. You must exercise sufficient control including frequent testing and recording of results to insure the equilibrium pH values are not higher than 4.6, as required by 21 CFR 114.80(a)(2). However, our investigators determined you are not monitoring the final equilibrium pH for any of your processed acidified food products, including Silva’s Mild Salsa,15 oz, Silva’s Hot Salsa, 15 oz Silva’s Mild Chunky Salsa, 31 oz and Silva’s Hot Chunky Salsa, 31 oz bottled in glass jars.Without proper testing, you cannot ensure the finished equilibrium pH values of your products are not higher than 4.6.
5. You must ensure each container is marked with an identifying code specifying the establishment where the product was packed, the product contained therein, the year, date, and period during which it was packed, as required by 21 CFR 114.80(b). However, our investigators observed containers of your acidified food products without an identifying code.
6. You failed to examine containers often enough to ensure the containers suitably protect food from leakage and contamination, as required by 21 CFR 114.80(a)(4). Specifically, you are not conducting any container testing or examination. Furthermore, you do not have a written procedure outlining the frequency of the examination or the manner in which the examination is conducted.
Further, deviations of the Current Good Manufacturing Practice (CGMP) regulations for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110), were identified by our investigators and documented on the form FDA-483, Inspectional Observations, issued to you.
These deviations included:
1. You failed to clean and sanitize all food contact surfaces, including food-contact surfaces of equipment, as frequently as necessary to protect against the introduction of microorganisms into food as required 21 CFR 110.35(d)(2). Specifically, during the inspection our investigators observed unclean food contact surfaces intended for manufacturing taco sauce and salsas.
2. You failed to clean and sanitize food containers used in the packaging of taco sauce and salsas in a manner which protects against contamination, as required by 21 CFR 110.80(b)(13)(ii). Specifically, you failed to clean and sanitize glass jars used in the packaging of taco sauce and salsas.
3. You failed to use a sanitizing agent adequately, as required by 21 CFR 110.35(d)(5). Specifically, you did not follow instructions for the sanitizing agent utilized on your food contact surfaces intended for manufacturing taco sauce and salsas.
This letter is not intended to be an all-inclusive list of violations which may exist at your facility or with respect to your products. You are responsible for ensuring your processing plant operates in compliance with the Act and all applicable regulations, including the Acidified Foods Regulations (21 CFR 114 & 108) and the Current Good Manufacturing Practice regulations (21 CFR Part 110).
You should take prompt action to correct the violations described in this letter and to establish and implement procedures which will prevent them from occurring in the future. Failure to implement lasting corrective action on violations may result in regulatory action by FDA without further notice. The Act authorizes actions such as injunctions against manufacturers and distributors of illegal products, the seizure of such products, and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit along with other possible legal actions.
Within fifteen (15) working days of your receipt of this letter, please notify this office in writing of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. You should include documentation to assist us in evaluating your corrections. If you cannot complete all corrections before 15 days, we expect an explanation for your delay and commitment to a time frame within which you will complete the remaining corrections.
If you have any questions regarding any issue in this letter, please contact Tamara J. Umscheid, Compliance Officer at 913-752-2434.
John W. Thorsky
Kansas City District Director