Inspections, Compliance, Enforcement, and Criminal Investigations
Bella Cucina Artful Food, Inc. 06-May-08
Department of Health and Human Services
Public Health Service
Atlanta District Office
May 6, 2008
VIA FEDERAL EXPRESS
Alisa Barry, Owner
Bella Cucina Artful Food, Inc.
1870 Murphy Avenue, SW
Atlanta, GA 30310
Dear Ms. Barry:
During the period of February 12 through 21, 2008, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1870 Murphy Avenue, SW, Atlanta, Georgia. The inspection revealed that you manufacture several varieties of acidified food products at this facility.
As a manufacturer of acidified food products, 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 Part 108), and Part 114, Acidified Foods (21 CFR Part 114). 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 acidified 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 114. In addition, based on certain criteria in Part 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. For your reference, the Act and the Emergency Permit Control and Acidified Food regulations can be located through FDA's homepage at http://www.fda.gov (http://www.cfsan.fda.gov/~comm/lacf-toc.html).
During the inspection, our investigators documented deviations from the Act and the above-mentioned regulations relating to the processing of the following acidified foods: Arugula and Pine Nut Pesto, Balsamic Mustard, Fresh Basil Pesto, Blood Orange Spread, Chestnut Honey Mustard, Farmhouse Olives, Farmhouse Sugo Sun-Dried Tomato & Caper Pasta Sauce, Key Lime Spread, Lemon and Garlic Marinated Chickpeas, Preserved Lemon Cream, Meyer Lemon Spread, Olivada Olive Pesto, Carmelized Onion, Golden Raisin & Fennel, Piccolo Pomodoro Tomato & Basil, Porcini and Parmesan Pesto, Sweet Pumpkin Pesto, Roasted Eggplant Pesto, Farmhouse Sugo All' Arrabiata Sauce, Farmhouse Sugo Peperonata Sauce, Sun-Dried Tomato Pesto, Roasted Sweet Balsamic Peppers, Sweet Pepper Pesto, Sweet Vidalia Onion Pesto, and Walnut Sage Pesto. These deviations cause your acidified food products to be adulterated and in violation of Section 402(a)(4) of the Act in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
The deviations of concern are as follows:
1. Your firm has failed to file a scheduled process for each of your acidified foods in each container size. At this time, none of your firm's acidified food scheduled processes have been filed with FDA. Scheduled process information for acidified foods must be submitted on Form FDA 2541 a (Processing Filing for all Processing Methods Except Low-Acid Aseptic) [21 CFR 108.25(c)(2)]. During the previous FDA inspection of your firm on September 28-29 and October 2-3, 2006, our investigators noted the same deviation regarding failure to file your acidified food scheduled processes with FDA. The most recent inspection of your firm also revealed that you received a letter dated November 9, 2006, from your processing authority, which stated: "Process filing must be done for each product by filling out and submitting Form FDA 2541 a (one for each product). This letter should be included in your submission as evidence of process issuance by a recognized processing authority."
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.cfsan.fda.gov/~comm/lacf-sl.html.
2. Your firm failed to manufacture, process, and package acidified foods, specifically Porcini and Parmesan Pesto, so that a finished equilibrium pH value of 4.6 or lower is achieved within the time designated in the scheduled process and maintained in all finished foods [21 CFR 114.80(a)(1)].
During the above inspection, our investigators collected and FDA analyzed a sample of Porcini and Parmesan Pesto, Lot #0081028, to determine the pH value. Lab results determined that the pH values of the sample (#407099) ranged from 4.66 to 4.98, with a mean pH of 4.84 (lab analysis results enclosed).
3. Your firm failed to maintain processing and production records showing adherence to the scheduled processes, including records of critical factors intended to ensure a safe product [21 CFR 114.100 (b)]. Specifically, on your production and processing records, your firm does not document the critical factor, as established by your processing authority, of holding your acidified foods at a minimum 160° F center container temperature for 1 minute.
4. Your firm failed to have personnel involved in acidification, pH control, heat treatment, or critical factors under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner [21 CFR 108.25(f)]. Inspection of your firm revealed that your Operations Manager and Kitchen Supervisor have not attended a Better Process Control school or an approved Acidified Food GMP school. Additionally, no one else at your firm was identified as having attended such training.
5. Your firm failed to adequately maintain instruments used for measuring conditions that control or prevent the growth of undesirable microorganisms [21 CFR 110.40(f)]. Specifically, inspection of your firm revealed that you do not calibrate the thermometers used to monitor the temperatures of the thermal process water and center container.
The above is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment is in compliance with all requirements of the Act and federal regulations.
You should take prompt action to correct these deviations. Failure to do so may result in regulatory action without further notice. These actions include seizure or issuance of an order of need for a Temporary Emergency Permit.
Additionally, we have the following comments based on observations made during the inspection:
• Your kitchen supervisor was observed pre-recording process end times on your processing records. To ensure the integrity of the data in your records, you should ensure that personnel are documenting operations as they occur and are recording only real-time values.
• Your Spinach and Artichoke Pesto has not been evaluated by a processing authority to determine if it is acidified. If your Spinach and Artichoke Pesto is an acidified food, it is subject to the requirements of 21 CFR Part 108, Subpart B, and Part 114.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the stated deviations, including an explanation of each step taken to prevent their recurrence. Your response should also indicate the person responsible for effecting corrective actions and include any supporting documentation indicating correction has been achieved. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deficiencies.
Your written response should be sent to James C. MacLaughlin, Compliance Officer, at the address noted in the letterhead. If you have any questions, please call Mr. MacLaughlin at 404-253-1220 or write to him at the address in the letterhead.
FDA lab analysis results for sample #407099