|Company:||A.G.S. Wholesalers, Inc.|
|Subject:||CGMP Regulation For Food/Adulterated/Misbranded|
|Issuer:||Los Angeles District Office|
|Issued:||Jan. 26, 2011||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Los Angeles District
RETURN RECEIPT REQUESTED
January 26, 2011
Anastasios Sotiropoulos, Owner
A.G.S. Wholesalers, Inc.
1419 S Alameda St.
Compton, CA, 90220-4901
Dear Mr. Sotiropoulos:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1419 S Alameda St, Compton, CA, 90220 on September 10-21, 2010. During the inspection, it was determined that your facility repackages acidified, fermented, and acid foods, and distributes other food products. The inspection revealed that your repacked cascabella pepper, sliced pepperocini pepper, sliced pickle, and whole pickle products are not labeled, and are therefore misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 343]. Regulations implementing the food labeling requirements of the Act are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). Additionally, your cascabella pepper, sliced pickle, and whole pickle products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. 342(c)] because they bear or contain an unsafe color additive. The inspection also revealed significant violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, at 21 CFR Part 110. Failure to manufacture foods in accordance with the CGMP requirements in 21 CFR Part 110 renders your firm's food products adulterated 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 unsanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath. The Act and FDA regulations can be found through links on FDA's webpage at www.FDA.gov .
Your significant violations were as follows:
Your cascabella pepper, sliced pickle, and whole pickle products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. 342(c)] because the products bear or contain a color additive which is unsafe within the meaning of section 721 (a) of the Act [21 USC 379(a)] Section 721(a) deems a color additive to be unsafe if its use is not in conformity with the color additive's listing regulation. Your cascabella pepper, sliced pickle and whole pickle products contain FD&C Yellow No.5. The listing regulation for FD&C Yellow No.5 requires that the color additive be listed by that name in the ingredient list in the labeling of foods for human use [21 CFR 74.705(d)(2)]. However, the labels for your cascabella pepper, sliced pickle and whole pickle products fail to declare the presence of FD&C Yellow No.5 in the ingredient statements.
During the inspection of your firm, it was observed that you fail to label your cascabella pepper, sliced pepperocini pepper, sliced pickle and whole pickle products that are repacked into fifteen gallon barrels. These products have the following labeling violations:
• Your cascabella pepper, sliced pickle, and whole pickle products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the products bear or contain artificial coloring, but fail to bear labeling stating such fact. In accordance with 21 CFR 101.22(k) the label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients. According to the ingredient statement of the products that you receive and repackage, your cascabella pepper, sliced pickle and whole pickle products contain certified color additives FD&C Yellow No.5. Under 21 CFR 101.22(k)(1), certified colors must be declared by the name of the color additive listed in the applicable regulation. The common or usual name may be abbreviated to omit the "FD&C" prefix and the term ''No.'' (e.g., Yellow 5).
• Your cascabella pepper, sliced pepperocini pepper, sliced pickle, and whole pickle products are misbranded within the meaning of section 403(i)(I) of the Act [21 U.S.C. § 343(i)(1)] because these products fail to bear a label with a statement of identity as required by 21 CFR 101.3.
• Your cascabella pepper, sliced pickle, and whole pickle products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are all fabricated from two or more ingredients and their labels fail to list the common or usual name of each ingredient.
• Your cascabella pepper, sliced pepperocini pepper, sliced pickle, and whole pickle products are misbranded within the meaning of section 403(e) of the Act [21 U.S.C. § 343(e)] in that the labels for these products do not bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5; and fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count in accordance with 21 CFR 101.105.
Current Good Manufacturing Practices
Our investigator documented a number of significant objectionable conditions relating to your facility's compliance with the CGMP regulations. Significant CGMP violations observed during the inspection include:
1. Your firm failed to perform packaging operations in a manner that protects food against contamination, including using food packaging materials that are safe and suitable as defined in 21 CFR 130.3(d), as required by 21 CFR 110.80(b)(13)(iii). Specifically, your cascabella pepper, pepperocini pepper, and sliced dill pickle products are packaged into can liners that are not suitable food packaging materials. According to the can liner manufacturer, the can liners you use to repackage these foods should not be used for storing food.
2. Your firm failed to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, our investigator found the following:
• Flying insects inside your food storage area.
• Ants on a box of lettuce and on a head of lettuce.
• Spider webs were observed in the immediate area where bags of onions were stored outside.
3. Your firm failed to provide adequate and convenient hand washing facilities as required by 21 CFR 110.37(e). Specifically, there is no hand washing sink in the area where you repackage foods that enables employees to wash their hands as necessary to protect against contamination.
Furthermore, the FDA has determined that your facility is subject to the registration requirement in section 415 of the Act, 21 U.S.C. § 350d, and our implementing regulation at 21 CFR Part 1, Subpart H. During our inspection of your facility located at 1419 S Alameda St, Compton, CA, 90220 on September 10-21, 2010 you were advised of this requirement. The failure to register a facility as required is a prohibited act under § 301(dd) of the Act, 21 U.S.C. § 331(dd). Our records indicate that, to date, this facility has not been registered with FDA.
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility's owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Registration may be accomplished on-line at http://www.access.fda.gov . We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all of your products are in compliance with applicable laws and regulations. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
In addition to the violations described above, we have the following additional comment regarding your repackaged acidified cascabella peppers. Please be advised that FDA has issued draft guidance that states that repackers of acidified foods are subject to the applicable requirements in 21 CFR Part 108.25 and 114. You may submit comments on this draft guidance to the agency as outlined in the document. The draft guidance is available online at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/AcidifiedandLow-AcidCannedFoods/ucm222618.htm
We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and include a timetable for the implementation of any remaining corrections.
Please send your reply to:
U.S. Food and Drug Administration
Attention: Blake Bevill
Director Compliance Branch
Los Angeles District
Irvine, CA, 92612-2506
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at 858-550-3850 x106.
Alonza E. Cruse District
Los Angeles District