Inspections, Compliance, Enforcement, and Criminal Investigations
Italian Rose Garlic Products, Inc 12/6/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
December 6, 2011
Mr. Kenneth J. Berger
Italian Rose Garlic Products, Inc.
1380 W 15th St.
Riviera Beach, FL 33404-5310
An inspection of your facility located at 1380 W 15th St, Riviera Beach, FL was conducted by investigators from the Food and Drug Administration (FDA) from August 17 to August 30, 2011. This inspection verified that your firm manufactures acidified food products.
As a manufacturer of acidified foods, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of acidified food products. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR 108), and Part 114, Acidified Foods (21 CFR 114). 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 acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration and filing of process information, and certain requirements of 21 CFR 114. In addition, based upon certain requirements in 21 CFR 114, acidified 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) [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. Your firm’s failure to fulfill certain requirements of 21 CFR 114 renders 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 the Acidified Food regulations through links on FDA’s home page at http://www.fda.gov.
Your significant violations of the acidified food regulations are as follows:
1. In accordance with 21 CFR 108.25(c)(3), a commercial processor engaged in processing acidified food shall process each food in conformity with at least the scheduled process filed under paragraph 108.25(c)(2). However your firm did not process products in conformity with at least the scheduled process as follows:
a) During the period between 5/22/2011 and 8/23/2011, your firm shipped 11 of 28 lots of shelf stable Garlic Spread and Garlic in Water, before the completion of a (b)(4) period following manufacturing as specified in the scheduled process established by your process authority. Your firm has filed a (b)(4). The (b)(4) determined by the challenge study conducted by (b)(4) as required to kill pathogens.
b) During the period between 01/17/2011 and 6/13/2011, your firm shipped 9 lots of Garlic Spread shelf stable, each having an equilibrium pH reading above 3.90, the maximum safe pH established by your process authority in the scheduled process for Garlic Spread shelf stable.
c) During the period between 4/13/2011 and 8/22/2011, you did not determine equilibrium pH prior to shipping 7 lots of Garlic Spread shelf stable and 2 lots of Garlic in Water shelf stable.
Your firm also failed to comply with provisions of 21 CFR 114.89 with respect to the above products. 21 CFR 114.89 requires that whenever any process operation deviates from the scheduled process for any acidified food and/or the equilibrium pH of the finished product is higher than 4.6, the commercial processor of the acidified food shall either: (a) Fully reprocess that portion of the food by a process established by a competent processing authority as adequate to ensure a safe product; (b) thermally process it as a low-acid food under part 113 of this chapter; or (c) set aside that portion of the food involved for further evaluation as to any potential public health significance. The evaluation shall be made by a competent processing authority and shall be in accordance with procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health. Unless the evaluation demonstrates that the food has undergone a process that has rendered it safe, the food set aside shall either be fully reprocessed to render it safe, or be destroyed. A record shall be made of the procedures used in the evaluation and the results. Either upon completion of full reprocessing and the attainment of a safe food, or after the determination that no significant potential for public health hazard exists, that portion of the food involved may be shipped in normal distribution. Otherwise, the portion of the food involved shall be destroyed.
2. The packing period code shall be changed often enough to enable ready identification of lots during their sale and distribution. Codes may be changed periodically on one of the following bases: intervals of 4 to 5 hours; personnel shift changes; or batches, as long as the containers constituting the batch do not represent those processed during more than one personnel shift as required by 21 CFR 114.80(b).
However, your firm failed to change your lot code for your acidified product, Garlic Spread shelf stable, lot #4074, with an expiration date of 02/18/2012, which your firm manufactured over the course of two personnel shifts during the period of 08/08-09/2011.
The above violations are not meant to be an all-inclusive list of the violations that exist in connection with your products. You are responsible for ensuring that all of your products are in compliance with the Act and FDA regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Such enforcement action may include seizure of illegal products and/or injunctions against manufacturers and distributors of illegal products [21 U.S.C. §§ 334 and 332].
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Carla A. Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issues in this letter, please contact Ms. Norris at (407) 475-4730.
Emma R. Singleton
Director, Florida District