Inspections, Compliance, Enforcement, and Criminal Investigations

U.L. Manufacturing Company Ltd. 11/16/17

 

  

Black HHS-Blue FDA Logo

 

5001 Campus Drive
College Park, MD 20740 

 
 

 

WARNING LETTER
 
NOV 16, 2017
 
 
VIA EXPRESS DELIVERY
 
Uriah Kelly, Managing Director
U.L. Manufacturing Company Ltd.
418 Cedar Place, Ebony Vale
Spanish Town P.O., Saint Catherine
Jamaica
Reference # 539712
 
Dear Mr. Kelly:
 
The U.S. Food and Drug Administration (FDA) inspected your acidified food (AF) facility, located at Dovecot Park, St. Johns Road, Spanish Town P.O., Saint Catherine, Jamaica on September 19, 2017. During that inspection we found that your firm had serious deviations from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108) and the Acidified Foods regulation (21 CFR Part 114). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the serious deviations found at your firm. We acknowledge receipt of your response received via email dated October 5, 2017, which included documentation describing corrections to the observations of concern noted on the form FDA-483. However, our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.
 
As a manufacturer of acidified food products intended for export to the United States, you are required to comply with the Food, Drug and Cosmetic Act (the Act) and the regulations promulgated under the Act, including those relating to the processing of acidified food products. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344.  A temporary emergency permit may be required for thermally processed low-acid foods packaged in hermetically sealed containers and acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR Part 114. Regulations specific to the processing of acidified food products are described in 21 CFR 108, and 21 CFR 114. 
 
As outlined in the regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25, and 21 CFR 114 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.25(j), for imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. Violation of the mandatory requirements set forth in 21 CFR 108.25, and 21 CFR 114 renders 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 Food regulations through links in FDA’s home page at www.fda.gov.
 
Your significant violations are as follows:
 
1.    You must file the scheduled processes with the FDA for each acidified food in each container size to comply with 21 CFR 108.25(c)(2). This filing must occur not later than 60 days after registration and prior to the packing of a new product and include conditions for heat processing; control of pH, salt, sugar, and preservative levels; and source and date of the establishment of the process, for each acidified food in each container size.  Specifically, as noted during the inspection, your firm failed to provide FDA with information and clarification previously requested through letters sent to your firm regarding the scheduled processes for your Crushed Pepper Sauce, Pimento Sauce, Meat and Steak Sauce and Fish and Meat Sauce. Consequently, due to a lack of scheduled process information these processes are not filed with FDA (i.e., no valid scheduled processes on file).
 
Your October 5th response states that you are in the process of refiling your Crushed Pepper Sauce with the FDA and hope to complete this in the next three weeks. However, to date our office has not received your process filings for your Crushed Pepper Sauce, or additionally for your Pimento Sauce, Meat and Steak Sauce, and Fish and Meat Sauce products.
 
Scheduled process information for acidified foods must be submitted on Form FDA 2541e (Food Process Filing for Acidified Method). More information on registration and filing can be found in the publication “Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format” available at http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm309376.htm.
 
2.    Your firm failed to maintain processing and production records showing adherence to the scheduled processes, including records of critical factors, as required by 21 CFR 114.100(b). Specifically,
 
a.  You did not record the “Production Time/Temperature” for “Hot Pepper Sauce” batches (b)(4). Your scheduled process for “Hot Pepper Sauce” requires a minimum cook temperature of 92°C for 5 minutes however record reviews revealed you did not record the start and end time or start and end temperature on your thermal process monitoring form for these three batches. 
 
b.  You did not maintain processing and production records for “Crushed Pepper Sauce” batches (b)(4); and for “Hot Pepper Sauce” batches (b)(4). Your scheduled processes for these products require specific times and temperatures, however during our inspection you had no processing or product records for these batches to ensure you achieved the required process times and temperatures.
 
c.  Your “(b)(4)” does not ensure that your firm achieves the full scheduled process for all batches. Record reviews revealed that your “(b)(4)” does not ensure that your firm achieves the full scheduled process for all batches. For example, (b)(4)
 
Your October 5th response states that your “(b)(4)” has been updated to reflect production time and temperature for all “Hot Pepper Sauces” and “Crushed Pepper Sauces” which you have promised to implement the next time these products are manufactured. However, we cannot evaluate the adequacy of your corrections without reviewing samples of your completed processing records that demonstrate your firm’s ability to adhere to your scheduled process and monitoring of critical values, which you have not provided.  
 
You should respond in writing within (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections such as copies of your updated process filings and completed processing records demonstrating your firm’s ability to adhere to your scheduled process and monitoring of critical factors. 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.
 
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported acidified food products under section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the acidified food regulations (21 CFR 108 and 114) is Import Alert #99-38, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods due to Inadequate Process Control. This alert can be found on FDA’s web site at https://www.accessdata.fda.gov/cms_ia/importalert_1132.html.
 
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the AF regulations (21 CFR Parts 108 and 114) and the current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the 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 reinspection-related costs. A reinspection 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 reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
 
Please send your reply to the Food and Drug Administration, Attention: Marco S. Esteves, Compliance Officer, Food Adulteration Assessment Branch, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A. 
 
If you have any questions regarding this letter, you may contact Marco S. Esteves via email at marco.esteves@fda.hhs.gov. Please reference CMS 539712 on any submissions and within the subject line of any emails to us. 
 
Sincerely,
/S/ 
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
      and Applied Nutrition
 

Page Last Updated: 02/01/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English