Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
May 15, 2014
VIA EXPRESS DELIVERY
Mr. Ranjith Attanayake, Director/Chairman
AMK Food Export (Pvt) Ltd
62, Katuwana Industrial Zone
Reference No. 428859
Dear Mr. Attanayake:
The U.S. Food and Drug Administration (FDA) inspected your processing facility located at 62, Katuwana Industrial Zone, Homogama, Homogama, Sri Lanka on December 9-10, 2013. During that inspection, FDA found that your facility had serious violations of the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR 108)); the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113); the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123); and the Current Good Manufacturing Practice regulation (21 CFR 110). At the conclusion of our inspection, the FDA investigator issued a form FDA-483, Inspectional Observations, listing the deviations found at your firm. We acknowledge receipt of your e-mail correspondence dated January 7, 2014, which included a letter describing your firm’s corrections to the FDA-483 observations along with supporting documentation. Review of your response and related documentation revealed that your firm has not made adequate corrections, as further described in this letter.
As a manufacturer of low-acid canned food (LACF) products intended for export to the United States, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act) and all applicable federal regulations. Regulations specific to the processing of LACF products are described in 21 CFR 108 and 21 CFR 113. As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.35 and 21 CFR 113 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 108.35(k), 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 108.35 and 21 CFR 113 renders your LACF 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 the LACF regulations through links in FDA’s home page at http://www.fda.gov.
Additionally, in accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4). Accordingly, your fish and fishery products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
You may find the Act, the LACF regulations, the seafood HACCP regulation, and the 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov. The Hazards Guide,which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our web site at: http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/seafood/ucm2018426.htm.
Your significant violations are as follows:
- As a commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers you must, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including but not limited to the processing method, type of retort or other thermal processing equipment employed, minimum initial temperatures, times and temperatures of processing, sterilizing value, or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process, for each such low-acid food in each container size, to comply with 21 CFR 108.35(c)(2). However, you have not filed a scheduled process with FDA for your LACF products, including but not limited to, your (b)(4) glass jars. Review of a few of your firm’s pH and water activity (Aw) analyses as conducted by your outside laboratory found varying results for your products’ pH values which may impact how to file the scheduled processes for your products.
Your firm is responsible for determining which regulations apply to the products that you manufacture, including whether products you manufacture are considered to be acidified food products, as defined in 21 CFR 114.3(b), subject to the applicable provisions of 21 CFR parts 108 and 114 or LACF products, as defined in 21 CFR 113.3(n), subject to the applicable provisions of 21 CFR parts 108 and 113. We acknowledge that your response indicates that you are working with a competent process authority to prepare the necessary scheduled processes for your products; however, we have not received any new scheduled processes at this time.
Scheduled process information for acidified or LACF products must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods,” available at: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/default.htm
- Your firm’s thermal processing records failed to include appropriate processing data for still retorts as required by 21 CFR 113.100(a)(1). Specifically, your process record for documenting the retort process does not include the following required parameters: time that steam is turned on; the time when retort reached processing temperature; the time that steam was shut off; and the venting time and temperature. We acknowledge that you have amended your “pasteurization log” to include the required process parameters and provided a copy of your amended record with your response; however, you did not include examples of completed records that demonstrate you have implemented the monitoring and recording of these parameters during production of your LACF products.
- Your firm failed to test your mercury-in-glass (MIG) thermometer against a known accurate standard as the reference instrument for indicating the process temperature of your steam in still retorts as required by 21 CFR 113.40(a)(1). Specifically, you did not calibrate your (b)(4) when it was installed. Your response indicates that you have scheduled a calibration of your (b)(4); however, there was no documentation submitted that supports the calibration occurred.
- Your firm failed to evaluate container closures by measuring the cold water vacuum of the glass container before the filling operation as required by 21 CFR 113.60(a)(2). Specifically, you do not conduct and document container closure examinations of LACF products packed in glass jars. Your firm’s response states that all glass jars and caps will be regularly checked and results recorded; however, you did not include examples of completed records that demonstrate you have implemented the monitoring and recording of these parameters during production of your LACF products.
Seafood HACCP violations
- You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels."
Your firm’s HACCP plan for (b)(4), does not list the critical control points for processing and storage of the (b)(4) (i.e., tuna) fish component, to control the food safety hazard of scombrotoxin (histamine) formation. Our inspection revealed that your firm uses (b)(4) fish (tuna) in the processing of your (b)(4) product. Tuna is a scombroid species of fish susceptible to scombrotoxin (histamine) development as a result of extended exposures to unrefrigerated/un-chilled conditions (i.e., time and temperature abuse). According to your Process Flow Diagram dated February 1, 2012, it appears that your firm conducts processing steps when the fish are not refrigerated and that your firm also stores in-process product for extended time periods in a cooler. Unrefrigerated processing steps can cumulatively result in time and temperature exposures conducive to scombrotoxin (histamine) formation. In order to prevent the formation of scombrotoxin (histamine), FDA recommends that firms ensure that controls are in place to monitor the cumulative time exposure of histamine-forming fish species during all unrefrigerated handling. In addition, FDA recommends that firms include critical control points during extended storage periods to ensure that fish are stored at adequate temperatures (i.e., at or below 4.4°C) or stored completely surrounded by adequate ice or cooling media. When held in refrigerated cooler, FDA further recommends that the coolers are equipped with continuous monitoring and recording devices. When held under ice or cooling media, FDA recommends monitoring the adequacy of ice or cooling media daily.
- You must have a HACCP plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard."
Your firm’s revised HACCP plan for “(b)(4)” provided with your response packet does not list critical limits to ensure that the fish are held at appropriate temperatures at the “(b)(4)” critical control point. Our investigator identified your firm as a secondary processor (i.e. receiving fish from another processor and not directly from the harvest vessel). As a secondary processor, your receiving critical control point should ensure that the incoming fish are properly chilled/refrigerated during transportation from the previous processor, by monitoring the transit conditions either via a record of refrigeration temperatures for the duration of the transit time to your facility; or by checking incoming fish to ensure that they are properly iced at the time of receipt.
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the LACF regulations (21 CFR 108 and 113), the acidified food regulation (21 CFR 108 and 114), the seafood HACCP regulation (21 CFR 123), and the current Good Manufacturing Practices regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations and should include documentation that would assist us in evaluating your corrections. Responding in English will help to assist us in our review of your documentation. 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 to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported LACF 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 LACF regulations (21 CFR 108 and 113) is Import Alert #99-04. This alert can be found on FDA’s web site at: http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm.
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 U.S. Food and Drug Administration, Attention: Robyn R. Jones, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Robyn.Jones@fda.hhs.gov. Please reference #428859 on any submissions and within the subject line of any emails to us. You may also contact Robyn R. Jones at (240) 402-2575 or email if you have any questions about this letter.
Office of Compliance
Center for Food Safety
and Applied Nutrition