Inspections, Compliance, Enforcement, and Criminal Investigations
Ito En (USA) Inc. 11/2/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Delivery Signature Requested
November 2, 2012
Leighton T. Horiuchi, President & COO
Ito En (USA) Inc.
125 Puuhale Road
Honolulu, Hawaii 96810
Ref: FEI 2915475
Dear Mr. Horiuchi:
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food facility located 125 Puuhale Road, Honolulu, Hawaii on June 25-28, 2012 and July 2, 2012. During that Inspection, we found that your firm had serious deviations from the low-acid canned food regulations (21 CFR Parts 108 and 113). As a manufacturer of low-acid food products, you are required to comply with the Federal Food, Drug & Cosmetic Act (the Act) and the federal regulations relating the processing of low-acid food products. The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act (21 U.S.C. §344). A temporary emergency permit may be required for low-acid foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 113. In addition, based upon certain criteria in 21 CFR Part 113, low-acid foods may be adulterated within the meaning of Section 402(a)(3) of the Act [21 U.S.C. § 342(a)(3)] in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or if they are otherwise unfit for food, or within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and the low-acid canned food regulations through links in FDA home page at www.fda.gov.
This inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection which listed the deviations found at your firm. Your firm’s July 13, 2012 and July 23, 2012 responses to the FDA-483 did not adequately address all of these deviations. We have the following remaining concerns with regard to your low-acid canned food products:
1. Your firm failed to process each low-acid canned food in conformity with at least the scheduled process filed with FDA, as required by 21 CFR 108.35(c)(3)(i). Specifically,
- Your scheduled process on file with FDA for your shelf-stable Iced Cappuccino in 11 oz. cans lists the critical factor of minimum process time of (B)(4). However, on March 13, 2012, your firm’s temperature recorder chart indicated the process times as (B)(4) for batch (B)(4) and (B)(4) for batch (B)(4). In addition, on January 12, 2012, your firm’s temperature recorder chart indicated the process time as (B)(4) for batch (B)(4).
- Your scheduled process on file with FDA for your shelf-stable Green Tea in 11.5 oz. cans lists the critical factor of minimum process time of (B)(4). However, on April 2, 2012, your firm’s temperature recorder chart indicated the process time as (B)(4) for batch (B)(4).
Your response indicates that all process deviations pointed out by our investigator have been subsequently reviewed by your process authority and none of the products pose a threat to consumers. In addition, you indicate that during future process deviations you will record the deviation in a log file, hold all affected product, and immediately send all process deviation information to your process authority for review. We will verify your implementation of these corrections during our next inspection.
2. Your firm failed to chlorinate or otherwise sanitize cooling water as necessary for cooling canals and recirculated water supplies, as required by 21 CFR 113.60(b). Specifically, your “Retort Recycle Water (2nd drain) Chlorine Concentration Form” indicates that on April 24, 2012 and June 22, 2012 there was no detectable chlorine in your recirculated cooling water.
Your response indicates that you will have a mechanic check the chlorinator and chemical level prior to startup each day and record the results on your amended chlorine concentration log, but you did not provide any copies of completed records as documented evidence.
3. Your firm failed to mark each hermetically sealed container with a code that identifies the product contained therein and the year packed, as required by 21 CFR 113.60(c). Specifically, your product coding system fails to identify the product contained therein and the year packed. Our investigator also observed finished product without any can coding.
Your response indicates that you have added the year packed to your can code; however, your response did not address the failure to mark each container with a code identifying the product contained therein nor did your address the failure to code every can.
This letter is not intended to be an all-inclusive list of deficiencies at your manufacturing facility. It is your responsibility to ensure that all of your products comply with the Act, the low-acid canned food regulations (21 CFR 108 and 113) and other applicable regulations.
You should take prompt action to correct the violations cited in this letter and to establish and implement procedures which will prevent them from occurring in the future. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice. The Act authorizes actions such as injunctions against manufacturers and distributors of illegal products, the seizure of such products, and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit along with other possible legal actions.
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that corrective action has been achieved. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.
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 non-compliance 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 domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your written response should be directed to Lawton Lum, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions with regard to this letter, please contact Brandon Bridgman, Compliance Officer at 510-337-6794.
Barbara J. Cassens
San Francisco District
U.S. Food and Drug Administration