- Gaea Products S.A.
- Issuing Office:
- Center for Food Safety and Applied Nutrition
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
APR 16, 2015
VIA EXPRESS DELIVERY
Mr. Aris Kefalogiannis, CEO
GAEA Products S.A.
48 Street Armatolon & Kelfton
11471 Athens, Greece
Reference No: 454758
Dear Mr. Kefalogiannis:
The U.S. Food and Drug Administration (FDA) inspected your acidified food (AF) processing facility, GAEA Products S.A., located at 1st Km National Road, Agrinio-Karpenisi 30100 Agrinio, Greece on January 8- 9, 2015. During that inspection we found your firm had serious violations of the acidified food regulations, Title 21, Code of Federal Regulations, Parts 108 and 114 (21 CFR Parts 108 and 114). At the conclusion of that inspection, our investigator issued an FDA Form 483, Inspectional Observations, which lists the observations of concern noted during the inspection. We acknowledge receipt of your responses dated January 30 and March 6, 2015. Our review of your response determined that your firm has not adequately addressed all of the deviations related to your AF products, as further described in this letter.
As a manufacturer of AF products, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act), and the federal regulations relating to the processing of the acidified food products you export to the United States. These regulations are described in 21 CFR 108, Emergency Permit Control and 21 CFR 114, Acidified Foods. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control (21 U.S.C. § 344). As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25 and 21 CFR 114 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.25(j), for imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. § 381) when offered for entry into the United States. Consequently, your violations of the mandatory requirements set forth in 21 CFR 108 and 114 render your AF 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 foods regulations through links in FDA's home page at www.fda.gov.
Your significant violations are as follows:
1. Your firm failed to process your Santorini Cooking Sauce in accordance with the filed scheduled process as required by 21 CFR 108.25(c)(3)(i). Specifically, your filed scheduled process (SID (b)(4)) identifies an initial temperature (IT) of (b)(4), a process time of (b)(4) minutes at (b)(4), and a maximum equilibrium pH of (b)(4). Your firm's operating process lists a maximum pH of below (b)(4) and minimum pasteurization time of (b)(4) minutes at (b)(4) (Zone (b)(4)) and (b)(4) (Zone (b)(4)).
Your firm's January 30, 2015, response indicated that you modified the process parameters based on a HACCP study which you attached to your response (Agreement with (b)(4) for validation and training); however, this exhibit contains only what appear to be references to food safety literature. Your response also indicated that a (b)(4) Food Science professor will conduct an updated literature based validation of the current operating parameters. The University response ((b)(4) Lethality treatment adequacy) is attached to your firm 's second email dated March 6, 2015. This exhibit also contains only what appears to be references to food safety literature. Yow- responses do not provide a thermal process study complete with data supporting your firm's operating process parameters for this product.
Your response also indicated that your firm will update the FDA form 2541a with the updated information accompanied by a copy of the validation study. However, to date, your firm has not submitted a revised scheduled process filing to FDA for this product.
2. Your firm failed to maintain processing records showing adherence to the scheduled processes, including records of critical factors intended to ensure a safe product as required by 21 CFR 114.100(b). Specifically, your firm failed to measure the initial temperature (IT) during processing of your Santorini Cooking Sauce.
Your response indicated that in March you will begin using a new form that will include all critical and quality factors. Your firm 's implementation of using this new form will be verified during the next inspection.
3. Your firm's operators of processing and packaging systems were not under the operating supervision of a person who completed a school approved by the Commissioner (Better Process Control School (BPCS)) as required by 21 CFR 114.10. Your firm responded that production is supervised by persons with university degrees in food processing. You will also have professors from the (b)(4) conduct an ad hoc course on food preservation and pasteurization by April. We note that having a degree in food processing does not satisfy the BPCS requirement. The BPCS is designed to educate your firm regarding better process control and the requirements of the GMPs.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation at least five (5) days of production records to demonstrate that you have implemented the revisions indicated in your response, and any other useful information that would assist us in evaluating your corrections. 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 to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported acidified 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 LACF and acidified food regulations (21 CFR 108, 113 and 114) is Import Alert #99-38. This alert can be found on FDA's web site at: http://www.accessdata.fda.gov/cms_ia/importalert_1132.html.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the acidified food regulations (21 CFR Parts 108 and 114), and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Additionally, 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. Are inspection is one or more inspections 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 re-inspection-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.
Please send your reply to the U. S. Food and Drug Administration, Attention: Donald W. Greaves, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment 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 Mr. Greaves at (240) 402-2057 or via email at email@example.com
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition