The company was cited for having an inadequate Food Safety plan, specifically, the company "did not identify and implement food allergen controls at the seasoning step adequate to significantly minimize or prevent the hazard of undeclared allergens as evidenced by [the] firm using cheddar and sour cream flavored seasoning instead of barbecue flavored seasoning while producing Sweet & Mesquite BBQ Flavored Potato Chips".
Basically, there was no substantial control to make sure the flavor added to the product matched the label on the bag in which the finished chips were packed. A pretty easy preventive control to implement, and perhaps one the company did not see as necessary because a simple control had worked in the past. Not this time. A simple error could have been easily been avoided by raising this to the level of a preventive control.
FDA Warning Letter
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/saratoga-potato-chips-llc-608017-09242020
Saratoga Potato Chips LLC
MARCS-CMS 608017 — September 24, 2020
MARCS-CMS 608017 — September 24, 2020
Recipient:
Peter Margie
President
Saratoga Potato Chips LLC
6923 Lincoln Pkwy
Fort Wayne, IN 46804-5677
United States
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
WARNING LETTER
FY20-HAFE6-WL-06
Reference # 608017
September 24, 2020
Dear Mr. Margie:
The United States Food and Drug Administration (FDA) has determined that you did not follow the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) (21 CFR Part 117). The failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)). You may find the Act and further information about the CGMP & PC rule through links in FDA's home page at http://www.fda.gov.
External Link Disclaimer
On February 18, 2020, after being notified by consumers that cheddar cheese flavored chips were found in bags of Kroger brand Sweet & Mesquite BBQ Flavored Potato Chips, your firm recalled Sweet & Mesquite BBQ Flavored Potato Chips. You indicated in your press release that the problem “was caused by an isolated incident of human error.” In documentation provided to the Office of Human and Animal Food Operations East Division 6 Recall Coordinator on February 19, 2020, your firm further stated that there had been “Human Error while feeding the seasoning in the hopper on production line. Cheddar & sour cream flavored seasoning used in production in place of Barbecue flavored seasoning. Cheddar & sour cream seasoning contains milk.” The documentation also stated that you will prevent a similar occurrence of the problem by “(b)(4).” (b)(5).
Preventive Controls
You did not identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (i.e., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed packed or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1) and (c)(2).
Specifically, you did not identify and implement food allergen controls at the seasoning step adequate to significantly minimize or prevent the hazard of undeclared allergens as evidenced by your firm using cheddar and sour cream flavored seasoning instead of barbecue flavored seasoning while producing Sweet & Mesquite BBQ Flavored Potato Chips. This ingredient addition error caused your product to contain an undeclared major food allergen.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.
(b)(5). If you would like to provide further details pertaining to the corrective actions taken by your firm and provide documentation, including revised procedures and completed monitoring records that would assist us in evaluating your corrections, please notify this office in writing within fifteen (15) working days of the receipt of this letter.
If you believe that your products are not in violation of the Act or that you have complied with FDA regulations, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Your written response should be directed to the Food and Drug Administration, attention to: Ms. Kathryn Cutajar, Compliance Officer, Office of Human and Animal Foods Operations, Division East 6, Compliance Branch, 300 River Place, Suite 5900, Detroit, MI 48207 or email at Kathryn.Cutajar@fda.hhs.gov. If you have questions regarding this letter, please contact Ms. Cutajar at 313-680-6962 or at the email address above.
Sincerely,
/S/
William R. Weissinger
Program Division Director
Office of Human and Animal Food Operations East-VI
Reference # 608017
September 24, 2020
Dear Mr. Margie:
The United States Food and Drug Administration (FDA) has determined that you did not follow the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) (21 CFR Part 117). The failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)). You may find the Act and further information about the CGMP & PC rule through links in FDA's home page at http://www.fda.gov.
External Link Disclaimer
On February 18, 2020, after being notified by consumers that cheddar cheese flavored chips were found in bags of Kroger brand Sweet & Mesquite BBQ Flavored Potato Chips, your firm recalled Sweet & Mesquite BBQ Flavored Potato Chips. You indicated in your press release that the problem “was caused by an isolated incident of human error.” In documentation provided to the Office of Human and Animal Food Operations East Division 6 Recall Coordinator on February 19, 2020, your firm further stated that there had been “Human Error while feeding the seasoning in the hopper on production line. Cheddar & sour cream flavored seasoning used in production in place of Barbecue flavored seasoning. Cheddar & sour cream seasoning contains milk.” The documentation also stated that you will prevent a similar occurrence of the problem by “(b)(4).” (b)(5).
Preventive Controls
You did not identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (i.e., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed packed or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1) and (c)(2).
Specifically, you did not identify and implement food allergen controls at the seasoning step adequate to significantly minimize or prevent the hazard of undeclared allergens as evidenced by your firm using cheddar and sour cream flavored seasoning instead of barbecue flavored seasoning while producing Sweet & Mesquite BBQ Flavored Potato Chips. This ingredient addition error caused your product to contain an undeclared major food allergen.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.
(b)(5). If you would like to provide further details pertaining to the corrective actions taken by your firm and provide documentation, including revised procedures and completed monitoring records that would assist us in evaluating your corrections, please notify this office in writing within fifteen (15) working days of the receipt of this letter.
If you believe that your products are not in violation of the Act or that you have complied with FDA regulations, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Your written response should be directed to the Food and Drug Administration, attention to: Ms. Kathryn Cutajar, Compliance Officer, Office of Human and Animal Foods Operations, Division East 6, Compliance Branch, 300 River Place, Suite 5900, Detroit, MI 48207 or email at Kathryn.Cutajar@fda.hhs.gov. If you have questions regarding this letter, please contact Ms. Cutajar at 313-680-6962 or at the email address above.
Sincerely,
/S/
William R. Weissinger
Program Division Director
Office of Human and Animal Food Operations East-VI
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