Inspections, Compliance, Enforcement, and Criminal Investigations
PARAYIL FOOD PRODUCTS PVT. LTD. 12/13/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
VIA EXPRESS DELIVERY
Mr. P.M. Mathew
Parayil Food Products Pvt. Ltd.
1/791-802, Industrial Development Area
Aroor, Aleppey 688534
Re: # 414411
Dear Mr. Mathew:
We inspected your seafood processing facility Parayil Food Products Pvt. Ltd., located at 1/791-802, Industrial Development Area, Aroor, Aleppey 688534, Kerala, India, on June 6 and 7, 2013. During that inspection, FDA found that your facility had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). Additionally, our inspection revealed that your firm violates the mandatory requirements set forth in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR 108) and Part 114, Acidified Foods (21 CFR 114), associated with your acidified food products. At the conclusion of the inspection, the FDA investigator issued a form FDA-483, Inspectional Observations, listing the observations found at your firm.
We acknowledge receipt of your responses sent via email on July 1, 2013 and September 4, 2013. Your responses included various documents, including a document describing corrections to the observations of concern noted on the FDA-483. However, relative to the seafood HACCP violations, you did not provide us with an updated HACCP plan. Our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.
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 Part 123, renders the fish or fishery products 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). Accordingly, your frozen scombrotoxin (histamine) forming fish and your shelf-stable dried and pickled fish products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
In addition, this inspection revealed that you are manufacturing acidified food products, such as acidified fish pickles. As a manufacturer of acidified foods, you are required to comply with the Act and the regulations relating to the processing of acidified food products. These regulations are described in 21 CFR 108 and 21 CFR 114. As outlined in these 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 such 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. In addition, 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 may find the Act, 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 can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
Your significant deviations are as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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 food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s HACCP plan for “(b)(4)” are not adequate because it does not list the necessary food safety hazards.
A. Your firm’s HACCP plan for “(b)(4)” does not list the food safety hazard of Clostridium botulinum growth and toxin formation for your vacuum-packaged products.
We acknowledge that, in your response, you stated that your firm has added Clostridium botulinum as a hazard and added a critical control point with the control measure to have appropriate labeling with “(b)(4)” on the packaging. However, this is not adequate, in that your firm did not provide a revised HACCP plan. In addition, your firm needs to include handling instructions that state the product should be kept frozen until used and thawed under refrigeration immediately before use. Moreover, the labeling and handling instructions need to be addressed in your HACCP plan. For example, once identified as a hazard, your plan needs to include a critical control point to visually check each lot of labels.
B. Your firm’s HACCP plan for “(b)(4)” collected during the inspection does not list the food safety hazard of Staphylococcus aureus growth and toxin formation. Staphylococcus aureus growth and toxin formation is a reasonably likely hazard that may occur during the drying process. Once identified as a hazard, your firm must ensure that you have implemented controls listed in your HACCP plan that are adequate to prevent toxin formation during the drying process until the dried fish achieve a moisture level that renders the fish shelf-stable.
2. 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." However, your firm’s HACCP plan for “(b)(4)” does not list critical control points for processing and refrigerated storage to control the food safety hazard of scombrotoxin (histamine) formation.
Our inspection revealed 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) and that the coolers are equipped with continuous monitoring and recording devices.
3. 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." However, your firm’s HACCP plan for “(b)(4)” and “(b)(4)” lists critical limits that are not adequate.
A. Your firm’s HACCP plan for “(b)(4)” collected during the inspection lists a critical limit, “(b)(4)” and “internal fish temperature, (b)(4),” at the Raw Material Receiving critical control point that is not adequate to control scombrotoxin (histamine) formation. We note that your response indicates that you have amended your HACCP plan to include “harvest vessel record” as a monitoring procedure and as a critical control point. However, your response does not indicate what critical limits are included on the record or any information on the monitoring frequency. For example, we recommend that harvest vessel records accompany each lot of fish that your firm receives and that those harvest vessel records include critical limits associated with time of death, the time the fish were placed on ice onboard the vessels, and any additional information to demonstrate that the fish were properly handled while onboard the vessels.
B. Your firm’s HACCP plans for “(b)(4)” do not list critical limits for decomposition/sensory evaluation at the “raw material receiving” critical control point to adequately control scombrotoxin (histamine) formation. Specifically, your plans do not indicate how many fish will be analyzed. We recommend that you conduct sensory examination of at least 118 fish, collected representatively throughout each lot (or the entire lot, for lots smaller than 118 fish); and, for fish held iced or refrigerated (not frozen) onboard the vessel, measure the internal temperature of a representative number of the largest fish in each lot, concentrating on any that show signs of having been mishandled (e.g., inadequately iced).
4. Predetermined corrective action plans included in a firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b).
A. Your corrective action plan for “(b)(4)” at the raw material receiving critical control point is not adequate to control scombrotoxin (histamine) formation. Your corrective actions list “If any decomposition reject the lot” and (b)(4).” These corrective actions do not address the initial cause that gave rise to the deviation. Therefore, we recommend that you also discontinue use of the supplier until evidence is obtained that the identified harvesting and onboard practices and controls have been improved to ensure that the causes of the critical limit deviations have been corrected.
B. Your corrective action plan for “(b)(4)” at the raw material receiving critical control point is not adequate to control scombrotoxin (histamine) formation. Your corrective actions list “If any decomposition reject the lot,” “(b)(4),” and “Reject the lot if not supplier guarantee.” These corrective actions do not address the initial cause that gave rise to the deviation. Therefore, we recommend that you also discontinue use of the supplier until evidence is obtained that the identified harvesting and onboard practices and controls have been improved to ensure that the causes of the critical limit deviations have been corrected.
1. Your firm failed to, 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 conditions for heat processing and 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, to comply with 21 CFR 108.25(c)(2). Specifically, you do not have scheduled processes on file with FDA for your acidified fish pickle products. Scheduled process information for acidified foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic) either electronically or by paper submission. Publications addressing both methods of filing can be found at: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ AcidifiedLACFRegistration/default.htm.
2. Your firm failed to register with the FDA as a commercial processor of acidified foods. A commercial processor of acidified foods is required, not later than 10 days after first engaging in the manufacture, processing, and packing of acidified foods, to register and file a Form 2541 with the FDA, as required by 21 CFR 108.25(c)(1).
Your September 9, 2014 e-mail correspondence to FDA stated that you “already applied on-line for the FCE number”; however, you did not provide the actual FCE number when asked and we could not locate your acidified foods facility in our LACF Online Database.
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 deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans; five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan or plans; documentation to show that you have submitted a scheduled process for your acidified foods (including your FCE number); processing records to show that you meet the processing requirements for acidified foods; and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the applicable laws and regulations. Submission of the information in English will assist in our review. 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 fish or fishery 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 seafood HACCP regulation is Import Alert #16-120. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.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 seafood HACCP regulation and the 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 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 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 consider providing a copy of this letter to your U.S. Agent.
Please send your reply to Food and Drug Administration, Attention: Asha Dwarka, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration and Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may send any information related to this case and/or any questions you may have regarding this letter to Asha Dwarka via email at: Asha.Dwarka@fda.hhs.gov
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition