| Public Health Service Food and Drug Administration |
| Washington, DC |
Department of Health and Human ServicesWARNING LETTER
August 5, 2010
VIA OVERNIGHT MAIL
Mr. Antonio Mancini
Managing Director
Madama Oliva, S.R.L.
Zone Industriale Localita Recocce
Carsoli, Aquila, 67061
Italy
Reference No.: 122393
Dear Mr. Mancini:
FDA inspected your low-acid canned food (LACF) and acidified food facility located at Zona Industriale Localita Recocce, Carsoli, 67061, Italy, on June 10-12, 2010. During that inspection, we found that your firm had serious deviations from the low-acid canned food regulations (21 CFR Parts 108 and 113). Failure to comply with all of the mandatory requirements of 21 CFR 108.35 and 21 CFR Part 113 constitutes a basis for the immediate application of the emergency permit control provisions of Section 404 of the Act and particularly implementation of 21 CFR 108.35(k) for products offered for entry into the United States. In addition, such failure renders your LACF 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 product, Black Cerignola Olives, is adulterated in that the product has been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health. You can find the Act and the low-acid canned food regulations through links in FDA's home page at http://www.fda.gov.
This inspection resulted in FDA's issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. Your firm provided a response to the FDA-483 via e-mail on June 18, 2010, and adequately addressed the seafood HACCP deviations. However, upon further review of the inspectional findings and documentation provided in your firm's responses, we have the following concerns with regard to your LACF products:
• Your firm failed to notify FDA's Center for Food Safety and Applied Nutrition (CFSAN) within 30 days after first use of the intentional changes to previously filed scheduled processes without obtaining substantiation by a qualified scientific authority as to the adequacy of the changes as required by 21 CFR 108.35(c)(2)(ii). Specifically, your firm lowered the initial temperature of your LACF black cerignola olives from (b)(4) as listed in your scheduled process filing (b)(4) as observed by our investigator. We acknowledge that you submitted a revised process filing (b)(4) to CFSAN's low-acid canned food staff; however, the filing was insufficient and returned on August 3, 2010.
• Your firm failed to determine and record the initial temperatures of the contents of the containers to be processed to ensure that the temperature of the product is no lower than the minimum initial temperature specified in the scheduled process as required by 21 CFR 113.87(c). Specifically, your firm does not monitor the initial temperature of containers for your LACF filed scheduled processes. Instead, you monitor a data logger temperature of one can in each retort basket, which varies from batch to batch. Your response indicates that you have created new processing records to be implemented; however, you did not provide actual completed records that demonstrate how your firm is determining and recording the initial temperatures of the cans.
• Your firm failed to perform teardown examinations for double-seam cans to ensure the maintenance of seam integrity as required by 21 CFR 113.60(a)(1). Your response indicates that you have prepared a form to record teardown measurements; however, you did not provide actual completed records which demonstrate your firm's ability to perform can seam teardown examinations.
• Your firm failed to record observations of visual closure examinations performed by a qualified person to ensure proper closure as required by 21 CFR 113.60(a). Specifically, observations of visual seam closure examinations are not recorded for your LACF products. Your response indicates that a new form has been created for the recording of visual closure examinations; however, you did not provide actual completed processing records that show the implementation of this new procedure.
• Your firm failed to use the mercury-in-glass (MIG) thermometer as the reference instrument for indicating the process temperature of your (b)(4) as required by 21 CFR 113.40(a)(1). Specifically, you do not monitor and record the temperature of the retort's MIG thermometer during thermal processing of your low-acid canned food products. In addition, your MIG thermometer was not tested against a known accurate standard thermometer yearly to ensure accuracy also required by 21 CFR 113.40(a)(1). Your response indicates that your MIG will be used as a reference thermometer and that records of the readings will be kept; however, you did not provide actual completed processing records that demonstrate that these temperatures are now recorded to provide assurance that the processing temperatures are met.
• Your firm failed to have evidence in the form of heat distribution data on file which demonstrates that adequate venting of air is accomplished in your horizontal still steam/air retort as required by 21 CFR 113.40(a)(12)(iii). (b)(4) as described in the FDA 483, differs from the specifications and diagrams in the regulation and you have no data that shows that the air is adequately vented in your configuration.
• Your firm failed to use heat sensitive indicators or other means to visually show that a thermal process has been applied to containers in retort baskets as required by 21 CFR 113.87(b). Your response indicates that heat sensitive tape will be applied to the baskets of the cans starting July 1, 2010; however, you should provide evidence that the correction has been made, such as records or photos.
• Your firm's operators of the retorts and persons who perform container closure examinations are not under the operating supervision of a person who has attended and successfully completed a thermal processing school approved by FDA, as required by 21 CFR 108.35(g). We acknowledge your firm's efforts to have a supervisor of operations and processing attend thermal processing school. There are institutions in Italy that can provide this training.
You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to further correct these violations. You should include in your response documentation that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) 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 low-acid canned food 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 canned food regulations (21 CFR Part 108 and 113) is Import Alert #99-04. This alert can be found on FDA's web site at: http://www.fda.gov/ForIndustry/ImportPrograrn/ImportAlerts/default.htm.
This letter may not list all the violations at your facility. You are responsible for ensuring that you firm operates in compliance with the Act, the low-acid canned food regulations (21 CFR Part 108 and 113), and the Current Good Manufacturing Practice regulation (21 CFR Part 110), and other applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the U. S. Food and Drug Administration, Attention: Robyn R. Jones, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Ms. Jones at (301) 436-2575 or via email at robyn.jones@fda.hhs.gov.
Sincerely,
/S/
Jennifer Thomas
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
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