Inspections, Compliance, Enforcement, and Criminal Investigations
Alabama Sunshine, Inc. 10/28/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
October 28, 2011
WARNING LETTER NO. 2012-NOL-03
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Fredrick G. Smith, President and Owner
Alabama Sunshine, Inc.
216 2nd Street NW
Fayette, Alabama 35555-2508
Dear Mr. Smith:
On July 11-13, 2011, a U. S. Food and Drug Administration (FDA) investigator inspected your firm, located at 216 2nd Street NW, Fayette, Alabama. The inspection revealed your firm manufactures acidified foods, including a variety of hot sauces, relishes, and salsas.
As a manufacturer of acidified foods, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act), and the federal regulations relating to the processing of acidified food products. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR 108) and 21 CFR 114, Acidified Foods. The Emergency Permit Control regulation was issued according to Section 404 of the Act [Title 21, United States Code (USC) 344]. A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108, Subpart B, including registration and filing of process information, and mandatory requirements of 21 CFR 114. You are also required to comply with the Current Good Manufacturing Practice (CGMP) regulation for foods (21 CFR 110). Based on certain criteria, an acidified food may be adulterated within the meaning of Section 402(a)(3) of the Act [21 USC 342(a)(3)] if it consists, in whole or in part, of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or, within the meaning of Section 402(a)(4) of the Act [21 USC 342(a)(4)], if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or may have been rendered injurious to health. You can find the Act and other relevant regulations through links in FDA’s Internet home page at http://www.fda.gov.
During the inspection, our investigator documented deviations from the Act and the above mentioned regulations relating to the processing of your acidified foods. These deviations cause your acidified food products to be adulterated and in violation of Section 402(a)(4) of the Act, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. The significant deviations found were as follows:
1. As a commercial processor engaged in the thermal processing of acidified foods you must, not later than 60 days after registration and prior to the packing of a new product, provide FDA information as to the scheduled processes, including conditions for heat processing and control of pH, salt, sugar, and preservative level, 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).
Specifically, you manufactured your acidified products and have not filed a scheduled process with FDA for your products for each container size.
Scheduled process information for acidified foods much 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/EstablishmentRegistrationThermalProcessFiling /Instructions/ucm2007436.htm.
For additional information on the types of products FDA considers to be acidified, please refer to the 2010 Draft Acidified Food Guidance Document at the following link: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/AcidifiedandLow-AcidCannedFoods/ucm222618.htm.
2. Your firm failed to establish scheduled processes of your acidified foods by using 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. Specifically, your firm does not have scheduled processes established by an acidified foods expert for all of your acidified food products.
3. You must maintain records identifying the initial distribution of your acidified products to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise unfit for their intended use, in accordance with 21 CFR 114.100(d). However, our inspection found you do not always maintain records identifying initial distribution of specific lots of your acidified products distributed via your firm’s Internet site or mail.
4. Your firm failed to prepare and maintain files along with a current procedure, including plans for recalling products that may be injurious to health, for identifying, collecting, warehousing, and controlling products; for determining the effectiveness of recalls; for notifying the FDA of any recalls; and, for implementing recall programs, as required by 21 CFR 108.25(e). Specifically, your firm has no procedures addressing recall.
5. Your firm failed to ensure instruments and controls used for measuring, regulating, or recording temperatures that control or prevent the growth of undesirable microorganisms in food are accurate and adequately maintained, as required by 21 CFR 110.40(f). Specifically, your firm does not maintain records documenting calibration of your processing temperature monitoring devices. Furthermore, while checking the processing temperature of a batch of hot sauce on July 12, 2011, our investigator’s calibrated thermometer read 8 degrees lower (i.e., 189° F) compared to your firm’s processing thermometer, which read 197° F.
6. Your firm failed to maintain effective measures to exclude pests from processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, on July 11, 2011, our investigator observed what appeared to be rodent excreta pellets in your firm’s retail sales room and mop room. On July 12, 2011, our investigator observed what appeared to be rodent excreta pellets throughout your firm’s retail sales room, warehouse room, processing room, preparation room and ingredient storage room, mop room and employee restroom.
7. Your firm failed to provide, where necessary, adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Our investigator observed openings with direct access to the exterior of the building that were sufficiently large enough to allow the entry of pests or rodents. Specifically, our investigation of your facility revealed: an approximate 3” x 1” opening below the main entry door located along the south wall; approximate 1’ x 1/2” and 2.5” x 1” openings at the bottom of the Warehouse Room entry door; and, an approximate 1’ x 1’ opening in a vent above the (b)(4) steam jacketed kettles in the Processing Room.
8. Your firm failed to identify, hold, and store toxic cleaning compounds, sanitizing agents, or pesticide chemicals in a manner to protect against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.35(b)(2). For example, on July 11, 2011, our investigator observed an unknown chemical inside a bottle labeled as (b)(4) Flavored Distilled Vinegar stored on the chemical shelf in the Mop Room.
9. Your firm failed to maintain the grounds, including properly storing equipment, removing litter and waste, and trimming weeds or grass within the immediate vicinity of the facility which may constitute an attractant, breeding place, or harborage for pests, as required by 21 CFR 110.20(a)(1). Specifically, on July 11, 2011, our investigator observed stored outside, near the facility’s north entrance: grass and weeds; a plastic bucket containing water; three mops; a bag of cans; nine, number 10 cans of ketchup; a plastic bag containing trash; a plastic bucket; and, a piece of lumber.
The above violations are not intended to be a comprehensive list of deficiencies at your facility. You are responsible for ensuring your facility operates in compliance with the Act, the Emergency Permit Control regulations (21 CFR 108), the Acidified Food regulations (21 CFR 114), and the CGMP regulations for food (21 CFR 110). It is also your responsibility to assure all your products are in compliance with all applicable federal regulations enforced by FDA.
You should take prompt action to correct all of the violations noted in this letter; and, you should establish procedures to ensure such violations do not recur. Failure to promptly do so may result in regulatory action without further notice, such as seizure, injunction, and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit.
You should notify this office in writing, within 15 working days from receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent recurrence. You should include in your response documentation, such as, copies of forms submitted to FDA, and other useful information to assist us in evaluating your corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed. Please address your reply to Rebecca A. Asente, Compliance Officer, at the address above. If you have questions regarding the contents of this letter, please contact Ms. Asente at (504) 832-1290, extension 1104.
Patricia K. Schafer
New Orleans District