Inspections, Compliance, Enforcement, and Criminal Investigations
Ozark Bottling Co
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
June 15, 2011
RETURN RECEIPT REQUESTED
Ref. KAN 2011-11
James M. Hughes, Owner
Ozark Bottling Co.
3468 Hwy 54/Osage Beach Parkway
Lake Ozark, MO 65049-1472
Dear Mr. Hughes:
On January 26 through February 8, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your facility located at 3468 Hwy 54/Osage Beach Parkway in Lake Ozark, Missouri. The inspection revealed that you manufacture several varieties of acidified food products at this facility.
We found that you have serious deviations from 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 Part 114). As a manufacturer of acidified 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 acidified food products. 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 food products whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 114. In addition, based on certain criteria in Part 114, acidified foods may be adulterated within the meaning of Section 402(a)(3) of the Act [21 U.S.C. § 342(a)(3)] in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. For your reference, the Act and the Emergency Permit Control and Acidified Food regulations can be located on the Internet through links on the FDA’s homepage 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 the following acidified foods: Black Angus Sweet & Tangy Veggie Salsa, Black Angus Sweet & Spicy Veggie Salsa, Hot Veggie Mix, Jasbo’s Mild Salsa, Jasbo’s Tequila Salsa, Jasbo’s Hot Salsa, and Jasbo’s XX Hot Salsa.
These deviations cause your acidified food products to be adulterated and in violation of Section 402(a)(4) of the Act, in that your acidified foods have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. These deviations were documented on the Form FDA 483, Inspectional Observations, which was issued to you on February 8, 2011.
The significant deviations from CFR Parts 108 and 114 which the investigator observed at your acidified food manufacturing facility are as follows:
* 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 the Food and Drug Administration information as to the scheduled processes including 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). Specifically, your firm failed to file a scheduled process for each of the following acidified foods you manufacture:
a. Black Angus Sweet and Tangy Veggie Salsa
b. Black Angus Sweet and Spicy Veggie Salsa
c. Hot Veggie Mix
d. Jasbo’s Mild Salsa
e. Jasbo’s Tequila Salsa
f. Jasbo’s Hot Salsa
g. Jasbo’s XX Hot Salsa
We acknowledge that your firm, in conjunction with your process authority, submitted scheduled process filings for these products received by FDA after the close of the inspection on February 15, 2011; however, these processes were evaluated and returned to your firm on March 14, 2011 for the reasons described in your return notices. Therefore, at this time, there are still no scheduled processes on file for these products. We recommend that your firm obtain further consultation from your process authority regarding each of the products’ least sterilization values (LSV), process source documentation, and process time and temperature before resubmitting the revised scheduled process filings.
* Your firm failed to maintain processing and production records showing adherence to the scheduled processes, including records of pH measurement and critical factors intended to ensure a safe product as required by 21 CFR 114.100(b). Specifically, production records do not demonstrate adherence to a scheduled process and record critical factors. For example:
a. Production records dated 6/24/2009, 1/15/2010, and March 17 (no year) for the “Hot Veggie Mix” manufactured by your firm do not contain at what point in processing the final pH was recorded or demonstrate evidence of a thermal process. In addition, some production records were not maintained for every batch of this product since 2008.
b. Production records dated 1/13/2011, 1/14/2011, 1/15/2011, 1/26/2011, and 1/27/2011 for two varieties of “Black Angus Salsa” do not show finished equilibrium pH measurements.
In addition, your firm failed to record pH meter calibration on a consistent basis. Specifically, pH meter calibration measurements are not recorded from May 22 to June 14, 2010 and from June 16 to July 10, 2010.
* Your firm failed to maintain production and processing records containing sufficient information such as product code and container size to permit a public health hazard evaluation of the processes applied to each lot and batch of production as required by 21 CFR 114.100(b). Specifically, production records for the seven acidified products manufactured by your firm do not contain sufficient information. For example:
a. Production records dated 6/24/2009, 1/15/2010, and Mar 17 (no year) for your “Hot Veggie Mix” do not indicate container size or lot size.
b. Production records dated 9/7/2010, 9/22/2010, 9/24/2010, no date, and 10/11/2010 for your four varieties of “Jasbo’s Salsa” do not indicate container size, lot size, or lot code.
c. Production records dated 1/13/2011, 1/14/2011, 1/15/2011, 1/26/2011, and 1/27/2011 for “Black Angus Salsa Sweet and Tangy” and “Black Angus Salsa Sweet and Spicy” do not indicate container size, lot size, or lot code.
* Your firm failed to maintain records of the examination of raw materials, packaging materials, finished products, and supplier’s guarantees or certificates to verify compliance with FDA regulations and guidelines or action levels as required by 21 CFR 114.100(a). Specifically, your firm does not maintain records of the examination of raw materials, packaging materials, and finished products.
* Your firm failed to prepare, review and retain at a reasonably accessible location for three years all records specified in 21 CFR 114, as required by 21 CFR 108.25(g). Specifically, your firm has been manufacturing “Hot Veggie Mix” for approximately three years. You were unable to provide production records for all batches of this acidified food manufactured at your firm.
The deviations identified above are not intended to be an all-inclusive list of deficiencies at your facility. Other violations can subject your food to legal action. It is your responsibility to ensure that your facility is in compliance with all requirements of the Act, the Emergency Permit Control regulations (21 CFR Part 108), the Acidified Food regulations (21 CFR Part 114), and the Good Manufacturing Practice regulations for food (21 CFR Part 110). It is also your responsibility to assure that all of your products are in compliance with applicable statutes enforced by FDA.
Our office is in receipt of your letter dated February 20, 2011 addressing the initial steps you are taking to correct the deviations noted on the Form FDA 483, Inspectional Observations, issued at the close of the inspection on February 8, 2011. We have reviewed this response and find the corrective actions, in general, to be inadequate, as the response appears to be isolated to the specifics of only one of the observations on the FDA 483. This response does not address the underlying causes of the other violations which may include ineffective oversight of personnel and record review. To date, your response does not provide assurance to our office that you have taken effective measures necessary to prevent recurrence of the deviations.
You should take prompt measures to correct all of the deviations noted in this letter. Failure to promptly correct these deviations 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 of receipt of this letter, of any additional steps you have taken to correct the noted deviations and to prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay, and the time within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Please direct your reply to Amy E. Devine, Compliance Officer, at the address listed above. If you have any questions regarding any issue in this letter, please contact Ms. Devine at the above phone number or address.
John W. Thorsky
Kansas City District