Patricia D. Holmes
- Holmes Made Salsa
2252 N. Coolidge Ave
Wichita, KS 67204
- Issuing Office:
- Kansas City District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
8050 Marshall Drive
Lenexa, Kansas 66214-1524913-495-5100
March 23, 2016
Ref. CMS # 489134
Patricia D. Holmes, Owner
Holmes Made Salsa
2252 N. Cooliage Ave.
Wichita, KS 67204-5612
Dear. Ms. Holmes:
On January 5-19, 2016, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 2252 N. Cooliage Ave., Wichita, KS 67204-5612, where you manufacture a variety of food, including acidified food products. The inspection revealed serious violations of the regulations for acidified foods (Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108) and Part 114, Acidified Foods (21 CFR Part 114)). Accordingly, we have determined that your acidified food products are 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 insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and the Acidified Food regulations through link in FDA’s home page at http://www.fda.gov.
As an acidified food processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods and current good manufacturing practices. These regulations are described in 21 CFR Part 108, Emergency Permit Control, and in 21 CFR 114, Acidified Foods. 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 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.
During our inspection, our investigators observed the following significant violations:
1. You failed to fully reprocess, thermally process as a low-acid food under 21 CFR 113, or set aside for further evaluation as to any potential public health significance, a portion of food which had an equilibrium pH of the finished product higher than 4.6, in accordance with 21
Specifically, you produced two batches of “Cowboy Candy” relish, which has an allowable, maximum equilibrium pH of (b)(4) per your Process Authority scheduled process and FDA filed process. Both batches were accepted and distributed to consumers without performing any corrective action such as reprocessing, processing as low acid food, or retaining for further evaluation. The batches are as follows:
• On 12/01/2015, (b)(4) / 14 oz. jars, lot DEC012017 were produced with a documented finished pH of 4.8.
• On 12/10/2015, (b)(4) / 14 oz. jars, lot DEC102017 were produced with a documented finished pH of 4.7.
Finished product in both batches were marked on associated production records as “accepted”, all product from the 12/1/2015 lot has been distributed, and (b)(4) of the (b)(4) / 14oz jars produced on 12/10/2015 has been distributed to retail outlets and/or individual consumers.
We acknowledge your response, received February 8, 2016, to this observation. However, in your response, you failed to identify how you will address any future process deviations as outlined in 21 CFR 114.89. Furthermore, your corrective actions for these two batches were not consistent with those outlined in 21 CFR 114.89. The regulation requires you to fully reprocess, thermally process as a low-acid food under 21 CFR 113, or set aside for further evaluation as to any potential public health significance, a portion of food which had an equilibrium pH of the finished product higher than 4.6. The evaluation shall be made by a competent processing authority and shall be in accordance with procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health according to the regulation. You have not provided evidence of these actions nor any follow-up actions.
2. Your firm failed to process each acidified food product in conformity with at least the scheduled process filed with FDA as required by 21 CFR 108.25(c)(3)(i). Specifically, all (b)(4) of your filed scheduled processes and process authority process source documentation identify a minimum initial temperature of (b)(4)°F and process time of (b)(4); however, you informed our investigators that (b)(4) of your (b)(4) products ((b)(4)) are (b)(4). Therefore, your actual processes and procedures conflict with your filed scheduled processes and offer no assurance that the product in the center of jar meets the time/temperature critical factors requirement to manufacture a safe product.
We acknowledge your firm’s response, received February 8, 2016, which stated corrective actions including, but not limited to, writing an SOP outlining each process for each product and contacting your process authority requesting updated process authority letters that match your exact process. However, your response did not include enough information to fully evaluate whether or not all of your (b)(4) products are manufactured according to the filed scheduled processes and process source documentation provided by your process authority.
We acknowledge the inclusion of three updated process letters for your (b)(4) which approve filling of the (b)(4), followed by (b)(4); however, according to our LACF database, you have not updated your current process filings to reflect these changes in accordance with 21 CFR 108.25(c)(2).
The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure your establishment is in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective actions may subject your firm and products to further actions, such as emergency permit control, injunction, or seizure.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)).
For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
You should notify this office in writing within fifteen (15) business days from your receipt of this letter, of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long term corrective actions, such as evidence that you are working with a process authority or your scheduled processes have been filed with the FDA. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.
Your written response should be sent to Jessica Hensley, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Dr., Suite 205, Lenexa, KS 66214 or Jessica.firstname.lastname@example.org.
If you have questions regarding any issues in this letter, please contact CO Hensley at 913-495-5183.
Cheryl A. Bigham
Kansas City District Director
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