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WARNING LETTER

KC Innovations, Inc MARCS-CMS 520084 —

Recipient:
KC Innovations, Inc

United States

Issuing Office:
Kansas City District Office

United States

 

  

Black HHS-Blue FDA Logo

 

 

 
Kansas City District Office
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100 

 

March 24, 2017

 

 
WARNING LETTER
 
 
CMS Case#: 520084
 
UPS RETURN RECEIPT REQUESTED
 
Antonia M. Ward, Owner and President
KC Innovations, Inc.
5400 Johnson Drive
Suite 253
Mission, KS 66205
 
 
Dear Ms. Ward,
 
We inspected your acidified food processing facility, located at 1206 E. 8th St., Kansas City, MO 64106 on January 12-26, 2017. The inspection revealed you manufacture acidified food products. As a manufacturer of acidified food products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act), and 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), Part 114, Acidified Foods (21 CFR 114), and Part 110 the Current Good Manufacturing Practice (21 CFR 110)1 regulations. 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 requirement of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR 114. In addition, based upon certain criteria in Part 114, acidified foods may be adulterated 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 condition whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
 
During the inspection, our investigators documented deviations from the Act and the above mentioned regulations relating to the processing of your acidified food products. The deviations cause your acidified food products to be adulterated and in violation of the 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. You can find the Act and the Acidified Food regulations through links in FDA’s Home page at www.fda.gov.
 
During our inspection, our observations were as follows:
 
1.    You failed to, 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, 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).
 
Specifically, your firm has failed to file a schedule process with FDA for the following acidified foods you manufacture and package, which have been determined to be acidified food products:
  • Raspberry Jalapeno Cheese Dip
Your firm also failed to file a scheduled process with FDA for each of the following product container sizes for the following acidified foods you manufacture and package:
  • Green Olive and Pimento Cheese Dip in 4 oz glass jars
  • Green Olive and Pimento Cheese Dip in 7 oz glass jars
  • Chipotle Cheese Dip in 4 oz glass jars
  • Chipotle Cheese Dip in 7 oz glass jars
  • Artichoke Leaf Cheese Dip in 7 oz glass jars
  • Raspberry Jalapeno Cheese Dip in 7 oz glass jars
  • Chocolatey Cherry Amaretto Cheesecake Fondue in 4 oz jars
Your response dated February 19, 2017 indicated you have resubmitted products to your process authority and are awaiting a response from them.  Your response did not provide any evidence you have submitted information to your process authority.
 
Scheduled process information for acidified foods must be submitted on Form FDA 2541a (Processing Filing for Acidified Method). More information on registration and filing can be found in the publication “Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format” available at: 76.htmhttp://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm3093
 
2.    You failed to adequately maintain instruments used for measuring, regulating, and recording conditions that control or prevent the growth of microorganisms, as required by 21 CFR 110.40(f).
 
Specifically, you were not calibrating your pH meter according to the directions stated in the user manual. On 01/12/2017, you demonstrated how to calibrate the pH meter by placing the pH meter in a (b)(4) buffer solution first and a (b)(4) buffer solution second, which were both at room temperature. You stated there is no particular order for which buffer solution to use first; you just grab and use whatever is closest. You did not have the owner’s manual for your pH meter at the start of the inspection.
 
Your response dated February 19, 2017 indicated, “Ph Meter is exercise in the proper use going by the Manual Directions.” However, you did not provide any evidence to support what procedure you implemented and how you understand it to be the proper procedure.

3.    You 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, the information contained in your production records does not adequately document adherence to the scheduled processes for your acidified food products including but not limited to Green Olive and Pimento Cheese Dip and Luscious Lemony Cheesecake Fondue.
 
Your 2016 production records for Green Olive and Pimento Cheese Dip show the following deficiencies:
  • No pH is recorded on one (1) of (b)(4) records, dated 6/8/2016.
  • No notation of (b)(4) 
  • No documentation of the date and time of pH readings or temperatures of the samples from which you obtained pH readings.
  • 13 of (b)(4) records do not identify start and end times and temperatures of the thermal process taking place during production.
The 2016 production records for Luscious Lemony Cheesecake Fondue show the following deficiencies:
  • No notation of  (b)(4),
  • No documentation of the date and time of pH readings or temperatures of the samples from which you obtained pH readings,
  • Nine (9) of (b)(4) records do not identify start and end times and temperatures of the thermal process taking place during production
Your response dated February 19, 2017, indicated, “The critical factors for processing Acidified Foods I have begun to show on my recipes, Start, End Time, Ph Time and date (b)(4) hours later. Deviation log has been implemented along with other fie logs. ( I will attach to my email.”  No evidence was provided to show the corrective actions and no deviation log has been received by the district.
 
4.    You failed to generate tracking documents for finished products distribution, as required by 21 CFR 114.100(d).
 
Specifically, you informed our investigators that you do not keep initial distribution records which contain the product lot numbers for any of your outgoing finished products.
 
Your response dated February 19, 2017 indicated you created and implemented an outbound product log to track finished product distribution, however you did not supply copies of completed records demonstrating implementation.
 
5.    You failed to note departures from scheduled processes having a possible bearing on public health or the safety of the food in a separate file or log that identifies departures from the scheduled process, the action taken to correct them, and the disposition of the product involved, as required by 21 CFR 114.100(c).
 
Specifically, investigators observed, during the review of production records, (seven) 7 of (b)(4) production records reviewed for Luscious Lemony Cheesecake Fondue product in 2016 documented pH values greater than the equilibrium pH identified by your process authority, yet you possess no records, or a log recording deviations, which identify the deviation, evaluate the product manufactured, or document the disposition of the batches of these products.
 
Your response dated February 19, 2017 indicated, “An email was sent asking what kind of variance can there be when measuring a PH”. There was no evidence of this email, or indication of where the email was sent.  During the inspection, you told the investigators a deviation book will be made up within the week and will use the book if the product falls out of the pH range. No evidence of the creation of this deviation book has been received by our District Office.
 
6.    You failed to mark each container with an identifying code specifying the product contained therein and date, as required by 21 CFR 114.80(b).
 
Specifically, your current product coding system for your entire product line does not allow for positive identification of the product within each container or its date of manufacture. The coding only states an expiration date.
 
Your response dated February 19, 2017 indicated, “I have not implement the coding system quite yet. I will have that completed before or by the end of the month and will submit.” To date, this coding system information has not been received by our District Office.
 
7.    You failed to prepare and maintain in files current procedures for recalling products that may be injurious to health, identifying, collecting, warehousing and controlling products, determining the effectiveness of recalls, notifying FDA and implementing recall programs, as required by 21 CFR 108.25(e).
 
Specifically, you do not have any written procedure delineating how to implement a recall, notify the FDA of this recall, or evaluate the effectiveness of your recall efforts.
 
Your response dated February 19, 2017 indicated, “The recall plan is close to complete, however I need addition time to complete.”  You have not provided specific information as to when this corrective action will be completed. This is significant because you have been notified of this observation during previous inspections.
 
8.    You failed to maintain records of the examination of raw materials, packaging materials and finished products to verify compliance with FDA regulations and guidelines or action levels, as required by 21 CFR 114.100(a).
 
Specifically, you maintain no records of examining raw materials, packaging supplies, or examination of finished products.
 
Your response dated February 19, 2017 indicated, “Observation on raw material are signed directly on the invoices.” Your response also included a Damaged Product List along with the response, which is a blank spreadsheet with columns for Date, Product Brand, Lot #, Problem with Ingredient or Packaging, and Results. However, you failed to provide sufficient evidence of this corrective action or any description of how or when the Damaged Product List is used.
 
9.    You failed to separate food consumption and beverages from your manufacturing area, as required by 21 CFR 110.10(b)(8).
 
Specifically, on 01/12/2017, during manufacturing, investigators observed two cups of coffee and a carton of half and half on the tables in the manufacturing area. You told our investigators, the coffee and half and half were for your own personal consumption during manufacturing.
 
Your response dated February 19, 2017, indicated “All beverages have been removed from the production area.” This is significant because this deviation was observed during a previous inspection, and you failed to report how you plan to monitor this to assure compliance in the future.
 
10.    Employees did not wash hands thoroughly in an adequate hand-washing facility after each absence from the work station, as required by 21 CFR 110.10(b)(3).
 
Specifically, on 01/12/2017 during production, an employee was observed leaving the production room to open the back exterior door, and returned to the production room to resume bottling the product without first washing their hands.
 
Your response dated February 19, 2017 indicated, “Signs are being posted when leaving the production and returning Hands are to be WASHED!”  No evidence was provided supporting this corrective action.
 
Our office is in receipt of your response dated February 19, 2017, 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 January 26, 2017. We have reviewed this response and provided comments below each item above.
 
The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that 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 action 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) working 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 process has 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 Andrew A. Hoopes, Compliance Officer, U.S. Food and Drug Administration at 210 Walnut St., Suite 369, Des Moines, IA 50309. If you have questions about this letter, please contact CO Hoopes at  andrew.hoopes@fda.hhs.gov or 515-244-0480, ext. 1002.
  

Sincerely,
/S/
Cheryl A. Bigham
District Director
Kansas City District Office
 
_________________________________________________
1 Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (CGMP & PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size. See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates for PC rule compliance dates.


 

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