- Food & Beverages
Current Good Manufacturing Practice (CGMP)
Recipient NameMarie-Charlotte Harden
- LaMarquise Inc.
1550 W. Lane Avenue
Upper Arlington, OH 43221-3921
- Issuing Office:
- Division of Human and Animal Food Operations East V
6751 Steger Drive
Cincinnati, OH 45237-3097
February 5, 2019
Warning Letter 558211
UNITED PARCEL SERVICE
Delivery Signature Requested
Marie-Charlotte Harden, CEO
La Marquise, Inc.
1550 W. Lane Avenue
Upper Arlington, Ohio 43221-3921
Dear Ms. Harden:
The U.S. Food and Drug Administration (FDA) inspected your bakery and central kitchen facility, located at 1550 W. Lane Avenue, Upper Arlington, Ohio, from June 4 - 8, 2018. The inspection focused on your Ready-to-Eat (RTE) cream-filled eclairs and revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule Title 21, Code of Regulations Part 117 (21 CFR 117) (CGMP & PC rule).
During our inspection of your facility, FDA investigators found serious violations of the CGMP & PC rule. Based on FDA’s inspectional findings observed during the inspection, we determined that food manufactured in your facility is 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 it was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health. In addition, 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 Internet home page at http://www.fda.gov.
At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing deviations found at your firm. However, to date we have not received a response to these inspectional observations.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
The CGMP & PC rule creates new requirements for covered facilities to perform a hazard analysis and establish and implement risk-based preventive controls for human food. The CGMP & PC rule provides that you must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control [ 21 CFR § 117.130(a)]. The CGMP & PC rule further provides that you must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under Section 402 of the Act or misbranded under Section 403(w) of the Act [21 CFR § 117.135(a)(1)].
Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135). Preventive controls are subject to preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140).
The CGMP & PC rule requires a food safety plan, which must include the following:
(1) The written hazard analysis, as required by § 117.130(a)(2);
(2) The written preventive controls, as required by § 117.135(b);
(3) The written supply-chain program, as required by subpart G;
(4) The written recall plan, as required by § 117.139(a);
(5) The written procedures for monitoring the implementation of the preventive controls, as required by § 117.145(a)(1);
(6) The written corrective action procedures, as required by § 117.150(a)(1); and
(7) The written verification procedures, as required by § 117.165(b).
However, you do not have a written food safety plan. Specifically, you did not prepare, or have prepared, and did not implement a food safety plan for the food manufactured in your central kitchen, such as RTE cream-filled eclair pastries, as required by 21 CFR § 117.126. Based on your operation, when you perform your hazard analysis you should consider hazards including contamination of products with environmental pathogens, such as Listeria monocytogenes and Salmonella, and food allergens.
Current Good Manufacturing Practice (Subpart B):
1. Your equipment and utensils are not designed and are not of such material and workmanship as to be adequately cleanable and are not maintained to protect against contamination and allergen cross-contact, as required by 21 CFR 117.40(a)(1). Specifically, on June 4, 2018, our investigator observed a stainless-steel mixing bowl with rough welds and dents on the inside of the bowl, which make it a surface that is not easily cleanable and that can harbor pathogens or allergen-containing food debris. The bowl was used on June 5, 2018, to mix dough for eclairs.
2. You did not clean your non-food contact surfaces in a manner and as frequently as necessary to protect against contamination and against allergen cross-contact, as required by 21 CFR 117.35(e). Specifically, our investigator observed the following,
a. Dust build-up was observed on the fan covers of the cooling unit in the quiche freezer, dairy cooler, pastry cooler, and bread freezer. Finished product was stored uncovered in these coolers and freezers.
b. Dust build-up was observed on the blower vent of the air conditioning unit. Racks of bread were stored below the vent to cool.
c. Dust build-up was observed on the air filter bracket above the rotary oven and retail prep area. Clean pots and containers were stored below this filter.
d. Dust build-up was observed on electrical cords and electrical outlets directly above the pastry prep table.
3. All persons working in direct contact with food, food-contact surfaces, and food packaging-materials must conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR 117.10(b). However, our investigator observed the following on June 5, 2018:
a. An employee was observed not wearing a beard net while placing fruit on top of fruit tarts. Additionally, the employee's shirt was touching some of the tarts.
b. An employee was observed wearing jewelry (a bracelet made of string) while making bread dough.
c. Employees' personal items, including coffee cups and shake containers, were stored under prep tables in the manufacturing areas. An employee was observed taking a drink of the coffee stored under the prep table and then continued prepping pastries without washing their hands.
d. An employee was observed filling eclairs with cream. When the employee was handed their cell phone, which was found on the floor, the employee placed the cell phone in their back pocket and continued to fill eclairs with cream, without washing their hands.
e. An employee was observed loading a truck for delivery. The employee entered the building and removed a tray of desserts from the pastry cooler. The employee then picked up a cake from the tray, touched the cake with his fingers, and placed the cake into a box. The employee did not wash their hands before touching the cake.
4. Food that can support the rapid growth of undesirable microorganisms must be held at temperatures that will prevent the food from becoming adulterated during manufacturing, processing, packing, and holding as required by 21 CFR 117.80(b)(3). Your dairy cooler is used to store dairy products, such as heavy whipping cream, pasteurized liquid egg, milk, pastry cream, chocolate ganache, and sweet dough, all of which are used to manufacture RTE pastries. You stated you visually inspect the temperature of the cooler (b)(4) and record it on the Cooler and Freezer Temperature record. From December 31, 2017 to June 2, 2018, your records show 104 out of 153 (b)(4) where the temperature of the cooler was recorded above (b)(4)°F, reaching as high as (b)(4)°F.
This letter is not intended to be an all-inclusive list of deficiencies in your plant. You are responsible for ensuring that your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable regulations.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 15 working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If corrective action cannot be completed within 15 working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Section 743 of the FDCA (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, 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 to your facility.
Your response should be sent to Kimberly A. Dutzek, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Drive, Building 200, Suite 500, Nashville, TN 37217. If you have any questions regarding this letter, you may contact Kimberly Dutzek at 615-366-7826 or via e-mail: email@example.com.
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East