- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameRobert M. Langlinais, Jr.
Recipient TitleOwner and CEO
- Langlinais’ Baking Company
814 West Congress St.
Lafayette, LA 70501
- Issuing Office:
- Office of Human and Animal Foods Operations-East
WARNING LETTER 625493
March 14, 2022
Dear Mr. Langlinais, Jr.:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) bakery located at 814 West Congress St, Lafayette, LA 70501 from November 1 through 5, 2021. Your facility manufactures various breads and rolls including French Bread and Sweet Roll Hamburger Buns. During our inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, the FDA investigators issued a Form FDA-483, Inspectional Observations, listing the violations found at your facility.
Based on FDA’s inspectional findings, we have determined that the RTE bread and roll products manufactured in your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 342(a)(4)] because they were 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. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive control’s 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 website at http://www.fda.gov.
To date, we have not received a response to the inspectional observations listed on the Form FDA-483, dated November 5, 2021.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. Your hazard analysis for RTE bread and roll products did not identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 117.130(a). Specifically:
a. Your hazard analysis did not identify and evaluate the hazard of undeclared allergens due to incorrect labeling at the packaging step to determine whether it is a hazard requiring a preventive control. Your facility manufactures and labels products which contain wheat (e.g., French Bread and Hot Dog Buns) as well as a product which contains both wheat and milk (Sweet Roll Hamburger Buns). Therefore, undeclared allergens due to incorrect labeling is a known or reasonably foreseeable hazard at the packaging step. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify undeclared allergens as a hazard requiring a preventive control. Preventive controls for food allergens include procedures, practices, and processes employed for labeling to ensure that all food allergens are included on the label (see 21 CFR 117.135(c)(2)(ii)). You did not have such controls in place as evidenced by your November 2021 recall of French Bread manufactured on November 1, due to undeclared wheat. Also, during the inspection you stated that in October 2021 you manufactured the same French Bread with the same label (not declaring wheat) and distributed it to the same customer. Further, we note that your written prerequisite “Allergen Control Program” does not include monitoring, corrective action, or verification procedures to ensure control of undeclared allergens.
b. Your hazard analysis did not identify and evaluate the hazard of allergen cross-contact to determine whether it is a hazard requiring a preventive control at the dough mixing and forming steps. You use butter, which contains milk, to manufacture Sweet Roll Hamburger Buns on mixing and forming equipment shared with products that do not contain this allergen (e.g., French Bread and Hot Dog Buns) on the same day. Allergen cross-contact could occur in products with different allergen profiles, without appropriate controls. Therefore, undeclared allergens due to incorrect labeling is a known or reasonably foreseeable hazard at the packaging step. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify allergen cross-contact as a hazard requiring a preventive control. Preventive controls for food allergens include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact, including during storage, handling and use (see 21 CFR 117.135(c)(2)(i)). We note that you stated during the inspection that Sweet Roll Hamburger Buns are sequenced (b)(4) However, your written prerequisite “Allergen Control Program” does not include this control measure.
2. Your hazard analysis did not evaluate environmental pathogens, such as Salmonella, to determine whether they are a hazard requiring a preventive control at the cooling and packaging steps, to comply with 21 CFR 117.130(c)(1)(ii). Your facility manufactures RTE bread and roll products which are exposed to the environment after being baked and until they are packaged. Your RTE packaged foods do not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens. A knowledgeable person manufacturing/processing food in your circumstances would identify environmental pathogens as a hazard requiring a preventive control (i.e., sanitation controls). Note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR 117.165(a)(3)).
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
3. You did not clean and sanitize equipment in a manner that protects against allergen cross-contact and against contamination of food and food-contact surfaces, as required by 21 CFR 117.35(a). On November 2, 2021, after a “(b)(4) clean” was conducted following production of Sweet Roll Hamburger Buns, FDA investigators observed two whole loaves of French Bread wedged between food-contact rollers on an overhead conveyor belt. FDA investigators also observed food residue on Mixer (b)(4) and on the (b)(4) dough forming equipment. This equipment is shared between Sweet Roll Hamburger Buns (which contain milk) and products which do not contain milk. Your sanitation manager had checked the equipment in this room and indicated it was “Go” on the “Post Cleaning Inspection” form.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your facility complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify FDA in writing, within 15 working days of the receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Christopher N. Dedeaux, Compliance Officer, via email at ORAHAFEAST5FirmResponses@fda.hhs.gov or at 404 BNA Drive, Suite 500, Nashville, TN 37217. You may reach Mr. Dedeaux at 504-846-6122 or via email at Christopher.Dedeaux@fda.hhs.gov if you have any questions about this matter.
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East