Inspections, Compliance, Enforcement, and Criminal Investigations
Accelerated Freeze Drying Co. Ltd. 6/2/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|5100 Paint Branch Parkway|
College Park, MD 20740
JUN 2, 2014
VIA EXPRESS DELIVERY
AJ Tharakan, Chairman
Accelerated Freeze Drying Co. Ltd.
C/o Amalgam House
Cochin, Kerala 682003 India
Dear Mr. Tharakan:
We inspected your seafood processing facility Accelerated Freeze Drying Co. Ltd., located at Ezhupunna P.O., Cherthala Taluk, Aleppey District, Kerala, India from December 12-13, 2013. During that inspection, we found that you had violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA 483, Inspectional Observations, listing the observations made at your firm.
We acknowledge receipt ofyour response sent via email on April 8, 2014. Your response included your revised HACCP plan for your freeze dried shrimp entitled "Rev. No 2 dated 27.12. 2013;" a thermal study entitled "Thermal Validation Report" conducted by the Central Institute of Fisheries Technology;" copies of completed monitoring records, photographs and a corrective action plan describing the corrections to the observations listed on the FDA 483. On May 8, 2014 your firm submitted a cover letter that provided detailed steps for your shrimp freeze drying process. We have assessed the responses and have continuing concerns 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 freeze dried shrimp 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 seafood HACCP regulation and the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on 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/GuidanceDocumentsRegulatorylnformation/Seafood/ucm2018426.htm
Your significant deviations are as follows:
1. 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 defmed 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 revised HACCP plan, submitted with your April 8, 2014 email, does not list necessary critical control points to control pathogen growth and toxin formation, as follows:
• Your firm's HACCP plan for "(b)(4)" does not list a critical control point (or multiple control points) for processing that occurs after (b)(4). In the cover letter provided May 8, 2014 you describe several phases (i.e., steps) referenced as Phases III-V that occur at temperatures between (b)(4). This (b)(4) at these (b)(4) temperatures should be included as a critical control point or multiple points to control the hazard of pathogen growth and toxin formation as a result of time and temperature abuse. Moreover, when product temperatures (b)(4), FDA recommends that cumulative exposure times be limited to 1 hour to control all reasonably likely pathogens that pose a risk as a result of time and temperature abuse. While your letter references the hazard of Staphylococcus aureus, this is not the sole pathogen of concern as a result of time and temperature abuse during processing. Consequently, we recommend that your firm ensure through a critical control point (or points) that the products are not cumulatively exposed to temperatures above 26.7°C for more than one (1) hour.
• Your firm's HACCP plan for "(b)(4)" does not list a critical control point for (b)(4) the product in the IQF tunnel before the product enters the (b)(4). According to your supporting documentation, (b)(4) the product before entering the (b)(4) is critical to the process to ensure the product is able to achieve the critical limit for moisture content that is needed during freeze drying; as this directly affects the operating parameters for the (b)(4). We recommend your firm list the critical factors needed to ensure the product is (b)(4) to proper temperature as required by the freeze drying process before entering the (b)(4). Alternatively, the critical control point for (b)(4) can list a critical limit for the product initial temperature at the start of that process.
2. 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)
• lists a critical limit of "(b)(4)" at the Batch Cooking critical control point that is not adequate to control pathogens (i.e., specifically Listeria monocytogenes) because these critical limits are not consistent with the limits identified in the supporting "(b)(4)" (i.e. validation study) conducted by the Central Institute of Fisheries Technology for your firm's product. The validation study is based on a (b)(4). Your critical limits appear lower than the target temperature from the study's targeted (b)(4). FDA recommends your firm either:
• refer to Table A-3 in Appendix 4 of the Guide as a guideline to establish critical limits when not implementing the limits provided in your validation study. For example, from Table A-3 at an (b)(4) the product should maintain a (b)(4) for at least (b)(4) while an internal (b)(4) (as currently listed in the HACCP plan) would require the product to maintain a (b)(4) for at (b)(4) of a 6D log reduction. Based on the cold spot for each run, your validation study shows that the product maintains a (b)(4) in that cold spot. Your data shows at an (b)(4) dependent upon the size of the shrimp in the hottest portion of the batch.
• establish your critical limits based on the validation study, as listed in the "(b)(4)" conducted by the Central Institute of Fisheries Technology. When establishing the limits listed in the validation study, your firm should list those critical limits consistent with the study. The study was conducted with a cooker temperature of (b)(4) with the initial core (b)(4). These critical factors should be listed as critical limits in addition to the time that is required to reach the product type specific core temperature. Your firm must provide scientific evidence that a (b)(4) maintained for at (b)(4) will achieve a 6D log reduction of Listeria monocytogenes in the shrimp or provide an equivalent level of safety assurance. Lower degrees of destruction (i.e., less than a 6D log reduction) may be acceptable when supported by a scientific study of the normal levels of pathogens in the product before cooking.
• Lists a critical limit of "(b)(4) should not (b)(4)." at the (b)(4) critical control point that is not adequate to control the hazard of pathogen growth and toxin formation. Since your product is (b)(4), S. aureus is not the sole pathogen hazard. FDA recommends all processing that occurs between 10-57°C be cumulatively limited to 1 hour or less. In addition to temperature, other critical factors necessary for the process should be identified as critical limits to ensure adequate drying to control for the hazard of pathogen growth in the finished product. These may include identifying the pressure necessary for water sublimation, air velocity, humidity, configuration of batch (e.g. shrimp size, thickness of layers in the tray), and minimum processing time.
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, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, 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 seafood HACCP regulation. 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.
Additionally, Section 743 ofthe 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 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 there-inspection and assessing and collecting there-inspection 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 re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
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.
Please send your reply to the Food and Drug Administration, Attention: Standra Purnell, Compliance Officer, Division of Enforcement, Office of Compliance (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Purnell via email at firstname.lastname@example.org.
Office of Compliance
Center for Food Safety
and Applied Nutrition