Department of
Health and Human Services
Public Health Service
Food and Drug
Administration
Kansas City District
Southwest Region
11630 West 80th Street
Lenexa, Kansas 66214-3340
Telephone: (913) 752-2100
July 12, 2012
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
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.
Sincerely,
/S/
John W. Thorsky
Kansas City District Director
