- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. Melvin Arroyo
- Campolor, Inc.
El Tuque Industrial Park, Bo. La Cuarta
Calle A, Edificio 2
Ponce, PR 00715
- Issuing Office:
- Center for Food Safety and Applied Nutrition
466 Avenida Fernández Juncos
San Juan 00901-3223
- (787) 729-8500
Dear Mr. Arroyo:
The U.S. Food and Drug Administration (FDA) inspected your facility located at El Tuque Industrial Park, Calle A, Edificio 2, Ponce, PR 00715 on September 18-21, 2018 (dates not all inclusive). During the inspection, we found your firm had serious violations of acidified food regulations, Title 21, Code of Federal Regulations, Part 114 (21 CFR 114). At the conclusion of the inspection, our investigator issued a Form FDA 483, Inspectional Observations, listing the deviations found at your firm. We acknowledge receipt of your firm’s written response dated October 2, 2018. Our evaluation of your written response to the deviations conveyed to you at the conclusion of the inspection are further described in this letter.
As a manufacturer of acidified food products, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act), and the federal regulations relating to the processing of acidified food products. Your violations of the requirements set forth in 21 CFR 114 render your acidified food products adulterated within the meaning of section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)). You can find the Act and acidified foods regulations through links in FDA's home page at www.fda.gov.
Your significant violations are as follows:
1. Your acidified food products are not manufactured in accordance with the scheduled process as per 21 CFR 114.80(a)(1).
Specifically, your firm filed scheduled processes with FDA for the products “(b)(4)” packed in 12 oz. glass jars and “(b)(4)” packed in 14 oz. glass jars. The scheduled processes filed for these sauces require hot filling the containers at a minimum of (b)(4)°F, holding them at that temperature in an inverted position for (b)(4) minutes, achieving a maximum finished product equilibrium pH of (b)(4), and conducting vacuum measurement as a container closure test.
- Thermal process temperatures were observed to be lower than the established (b)(4)°F but your firm failed to document and identify the problem and did not take corrective actions.
- Glass jars of hot-filled sauces were not inverted after filling to ensure sterilization of the container lid and head space.
- Initial time, temperature and pH of the products, at the start of the filling process, were not measured.
- Following hot filling, the temperature of the product in the container after the end of the holding time of (b)(4) minutes and the finished equilibrium pH of the food were not measured.
- You did not conduct the required vacuum test and/or examine the jars to ensure that the containers suitably protected the food from leakage and contamination.
- Your firm’s scheduled process and product formulation for “(b)(4)” establishes the use of sodium benzoate as a microbial preservative. However, your firm does not use sodium benzoate in the product formulation since approximately 2016 as verbally stated to the investigator during the inspection.
Your written response dated October 2, 2018, stated you hired a process authority to make the changes to the scheduled processes and records filed with FDA for your acidified products. However, your response is inadequate. Your response does not indicate what practices or procedures your firm has implemented to ensure acidified products you currently manufacture receive adequate thermal processing and acidification.
2. A scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods in accordance with 21 CFR 114.83.
Specifically, your firm has performed changes in raw material, product formulation, preserving agents, and other conditions that could affect attainment or control of the equilibrium pH of your acidified products without having the changes evaluated by a processing authority or notifying FDA of changes to your scheduled process.
Your written response dated October 2, 2018, is inadequate. Your response did not address what corrective actions your firm has implemented for acidified products your firm manufactures pending process evaluation from a process authority.
3. Your facility operators of processing and packaging systems are not under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner in accordance with 21 CFR 114.10.
Your response to the observation stated you hired an individual responsible for quality control operations. However, your response is inadequate. The hired individual has no experience related to foods. Also, your response failed to provide information describing the individual qualifications pertaining to food, particularly, acidified food regulation training and current Good Manufacturing Practices applicable to your firm’s manufacturing operation.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you have taken to correct these violations. You should include in your response, documentation, such as, at least five (5) days of production records, to demonstrate that you have implemented the revisions indicated in your response and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as seizure or injunction.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including acidified food regulations (21 CFR 114). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Additionally, 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 mean 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 foreign facility, FDA will assess and collect fees for re-inspection related costs from the U.S. Agent for the foreign 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.
Please send your reply to the U.S. Food and Drug Administration, Mr. Ramon Hernandez, Director, San Juan District, Office of Human and Animal Food Operations Division East IV, 466 Fernandez Juncos Ave., San Juan, Puerto Rico 00901.
If you have any questions regarding this letter, please contact Ms. Pearl Gonzalez, Compliance Officer at telephone number (407) 475-4730 or via email at email@example.com.
Ramon A. Hernandez
Director, San Juan District Office and
Program Division Director,
Office of Human and Animal Food Operations
Division IV East