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WARNING LETTER

Sweet Ann Cake, Inc. MARCS-CMS 590155 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Francisco Aguayo Medina, President
Recipient Title
President
Sweet Ann Cake, Inc.

Carr #867 Km 7.8 Lote #3
Calle Bruno Cruz, Zona Industrial
Toa Baja 00949
Puerto Rico

Issuing Office:
Office of Human and Animal Food Operations East Division IV

United States



WARNING LETTER
20-HAFE4-WL-02 / CMS No. 590155


Dear Mr. Aguayo Medina:

The U.S. Food and Drug Administration (FDA) inspected your Ready-to-Eat (RTE) bakery products manufacturing facility located in Toa Baja, Puerto Rico from June 24, 2019 through July 19, 2019 (dates not all inclusive). During our inspection of your facility, 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 (CFR), Part 117 (21 CFR Part 117).

Based on FDA’s inspectional findings, we determined that the bakery 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 U.S.C. § 342(a)(4)) in that they were prepared, packed, or held under insanitary conditions whereby they may have been 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 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.

FDA’s inspection resulted in issuance of an FDA Form-483 (FDA-483), Inspectional Observations, listing deviations found during our inspection. We received your firm’s response to the FDA-483 on August 1, 2019, which included a written description of your corrective actions. Evaluation of your response is provided below.

We found the following significant violations:

21 CFR Part 117 – Subpart C, Hazard Analysis and Risk-Based Preventive Controls

1. You did not conduct a hazard analysis for any of your products to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured or processed at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR §117.130(a). Specifically,

a. You did not identify allergen cross-contact as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control. Your facility manufactures multiple products with different allergen profiles on the same day and on shared equipment.

b. You did not identify pathogens, such as Clostridium botulinum, pathogenic Escherichia coli, Salmonella, and/or Staphylococcus aureus, as a known or reasonably foreseeable hazard to determine whether pathogens are a hazard requiring a preventive control. Your facility manufactures multiple products with wheat flour, peanuts, and/or tree nuts (such as almonds). These ingredients have been associated with pathogens.

c. You did not evaluate environmental pathogens, such as Listeria monocytogenes and Salmonella, as a known or reasonably foreseeable hazard to determine whether environmental pathogens are a hazard requiring a preventive control to comply with 21 CFR §117.130(c)(1)(ii). Specifically, your facility manufactures RTE food which is exposed to the environment prior to packaging. The packaged foods, such as your mousse products that contain unpasteurized eggs, do not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. In addition, after your baked products have undergone (b)(4), they are re-exposed to the environment uncovered and held under ambient temperature without refrigeration for an extended period of time before being processed or packaged for distribution.

d. You did not identify mycotoxins as a known or reasonably foreseeable hazard to determine whether mycotoxins are a hazard requiring a preventive control. Your facility manufactures multiple products with wheat flour, peanuts, and/or tree nuts (such as almonds). These ingredients have been associated with mycotoxins.

Your response does not address conducting a hazard analysis to identify and evaluate biological, chemical, physical and any other hazards for each food your firm manufactures to determine whether there are any hazards requiring a preventive control.

2. You did not prepare, or have prepared, and did not implement a food safety plan for the food products manufactured in your facility, as required by 21 CFR §117.126(a)(1). Your food products may have biological, chemical, and physical hazards which could require process, allergen, sanitation, and supplier controls.

In your written response, you indicate that you have hired an outside consultant to assist you to develop your Food Safety Plan. We will assess the adequacy and implementation of your Food Safety Plan during the next FDA inspection.

3. You did not identify and implement preventive controls (e.g., process controls, allergen controls, and supply-chain controls) for any of your products to provide assurance that any hazards requiring a preventive control will be significantly minimized or prevented, as required by 21 CFR §117.135(a). In addition, you did not establish and implement written procedures for monitoring, written corrective action procedures, or conduct verification activities, as required by 21 CFR §117.140 - §117.165.

Your response indicates that you will be providing information to employees on a number of food safety-related topics; however, your response does not address what preventive controls you are currently using or will be implementing to significantly minimize or prevent hazards associated with the food products your facility manufactures.

21 CFR Part 117 – Subpart B, Current Good Manufacturing Practices

1. You failed to take effective measures to exclude pests from the manufacturing, processing, packing, or holding areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR §117.35(c), and as evidenced by the following:

a. Apparent rodent excreta pellets were observed in the following areas:

• Too numerous to count in the (b)(4) area where a variety of paper bags of ingredients such as creme cake base, white cake mix, baking powder, and the paper towel used for drying hands are stored; and
(b)(4) on the floor of the (b)(4) area next to a storage rack where cleaned baking pans were stored.

b. A bird’s nest with two live birds and bird droppings were observed at the entry ramp to the (b)(4) dock where distribution trucks were loaded with unpackaged and partially uncovered RTE bakery products.

c. Flying insects were observed in the production area where RTE cheesecakes and cakes are decorated, flying over food contact surfaces of (b)(4) tables and racks with RTE bakery products ready for distribution. One flying insect was observed to have landed on the food contact surface (b)(4) table and a measuring cup in the (b)(4) production area.

d. The door leading from the exterior of the facility to the production area has gaps along its bottom, middle section, and the sides, ranging from (b)(4) inches wide.

e. (b)(4) leading from the exterior of the facility to the production area were observed uncovered, providing easy access for pests to enter the facility.

Your response states that your firm is working with a pest control company and that you installed (b)(4) lamps and (b)(4) traps. However, your response does not address gaps and openings observed throughout your facility which may serve as potential rodent entryways.

2. You did not adequately maintain your equipment and utensils to protect against allergen cross-contact and contamination, as required by 21 CFR §117.40. Specifically, our investigator observed the following:

a. Knives used to test if the bakery products are fully cooked, cut the crust, and sculp the RTE bakery products were held in contact with dirty surfaces and used to open dusty packages of ingredients without being cleaned and sanitized prior to using on the RTE bakery products.

b. Processing utensils and tools such as measuring cups, sifters, and spatulas were dirty with old food residues and/or corroded parts.

c. An employee dropped a spatula that is used to glaze the RTE cheesecake on the floor and then returned it to the (b)(4) table.

3. You did not clean food contact surfaces of equipment as frequently as necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR §117.35(d). Specifically, product contact surfaces of working tables used for raw and finished product preparations were not cleaned and sanitized before use and/or between uses.

4. You did not store clean and sanitized (b)(4) equipment with food-contact surfaces and utensils in a location and manner that protects food contact surfaces from allergen cross-contact and from contamination, as required by 21 CFR §117.35(f). Specifically, our investigator observed processing utensils, such as clean baking pans and baking sheets, stored uncovered under processing tables that had rusted parts, accumulated dirt, and old food residue underneath the tables. Furthermore, product contact surfaces of the clean baking pans and trays used to hold RTE product were in direct contact with the corroded parts of the tables. In addition, product contact surfaces of the clean baking pans and trays were in direct contact with corroded metal and (b)(4) surfaces of a storage rack.

5. An employee did not wash his hands thoroughly in an adequate hand-washing facility when his hands may have become soiled or contaminated, as required by 21 CFR §117.10(b)(3). Specifically, prior to an employee decorating RTE cheesecakes with his bare hands, he was observed scratching his arms and touching dirty surfaces around the production area, such as a visibly dirty shopping cart, (b)(4) cartons, and dirty processing tools without washing his hands between changing tasks and handling RTE products.

6. You did not maintain your plant in a clean and sanitary condition, as required by 21 CFR §117.35(a). Specifically, our investigator observed the following:

a. Your uncovered RTE products were exposed to dust build-up and an apparent black mold-like substance on the ceiling of the (b)(4) cooler.

b. There was mold on the door frame and (b)(4) curtain at the entrance to the (b)(4) cooler, through which you transport uncovered RTE bakery products.

7. You did not maintain your plumbing adequately to avoid it constituting a source of contamination to food, water supplies, equipment, or utensils or creating an insanitary condition, as required by 21 CFR §117.37(b)(3). Specifically, our investigator observed the following:

a. The outer surface of the hoses used to provide (b)(4) water in the processing area, including use by employees to rinse their hands and utensils, was visibly dirty.

b. Employees obtained (b)(4) water from an (b)(4) hose attached to a water (b)(4) cartridge on the (b)(4) water line.

In your written response, you indicate that you will be creating procedures to implement corrective actions needed to protect food from adulteration, and that your employees will be taking training. However, you have not provided copies of your procedures or records of employee training. We will assess the adequacy and implementation of your procedures during the next FDA inspection.

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 requirements. 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.

Section 743 of the Act, (21 USC 379j-31), authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection-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. Reinspection-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 reinspection fees, [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.

Please respond within fifteen (15) working days of the receipt of this letter with the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. You should include documentation in your response, including photographs, food safety plans(s), procedures, or other useful information that would assist us in evaluating your corrections. 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 the corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be implemented.

Please send your reply to the Food and Drug Administration, San Juan District Office, 466 Fernández Juncos Avenue, San Juan, PR 00901-3223, to the attention of Ramon A. Hernandez, District Director.

If you have any questions about this letter, you can contact Ms. Pearl Lopina, Compliance Officer, via telephone at (407) 475-4730 or email at pearl.lopina@fda.hhs.gov.

Sincerely,
/S/

Ramon A. Hernandez
District Director, San Juan District
Program Division Director
OHAFO East Division IV