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 email@example.com or 515-244-0480, ext. 1002.
Cheryl A. Bigham
Kansas City District Office