Inspections, Compliance, Enforcement, and Criminal Investigations

Sami's Pita Bakery, Inc. 10/26/16

 

  

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Florida District Office
555 Winderley Place, Suite 200
Maitland, Florida 32751 

 

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w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-17-01
October 26, 2016
 
 
 
Mr. Sami (NMI) Chehab, President
Sami’s Pita Bakery, Inc.
2399 E. Busch Blvd
Tampa, FL 33612-8407
 
Dear Mr. Chehab,
 
The U.S. Food and Drug Administration conducted an inspection at your manufacturing facility located at 2399 E. Busch Blvd, Tampa, FL 33612 from March 21 through March 29, 2016. The inspection found significant violations of the FDA’s Current Good Manufacturing Practice (CGMP) regulation in manufacturing, packing or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the foods manufactured at your facilities to be 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)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. The product labeling collected during the inspection underwent review and significant violations of the FDA’s Food Labeling regulation, Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101) were identified. These violations cause the foods to be misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)], 403 (i)(2) of the Act [21 U.S.C. 343 (i)(2)] and 15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act (FALCPA). You can find the Act and its implementing regulations on FDA’s home page www.fda.gov.
 
To date, we have not received a written response to the Form FDA 483 List of Inspectional Observations that was issued.
 
Adulteration
 
1.    Your firm failed to manufacture food under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food, as required by 21 CFR 110.80(b)(2). More specifically, your firm manufactures bakery products containing soy, wheat, and tree nuts (either alone or in combination), with other bakery products that do not contain any or all of those ingredients. These products are manufactured on shared equipment including mixers and dough dividers that are not sequenced or cleaned in between batches of products which do contain and do not contain those ingredients.
 
FDA has received four (4) complaints between 2007 and 2016 which alleged concerns regarding the presence of gluten or wheat in products manufactured by your firm which are not listed as ingredients on the product labeling, including one consumer who stated they have Celiac disease and had a strong reaction to millet bread manufactured by your firm.
 
2.    You must store liquid and dry raw materials and other ingredients received and stored in bulk form shall be held in a manner which protects against contamination, as required by 21CFR 110.80(a)(7). 
 
Specifically, FDA investigators observed approximately (b)(4) raw ingredient storage bins within your facility which contained no identifying marks to indicate the dry raw ingredient stored within. Wheat gluten was observed to not contain a label, which was stored directly adjacent to a bin of rice flour. Many of the ingredients were similar in appearance and included items that were allergens (wheat gluten) or food additives (calcium propionate). 
 
3.    You must maintain equipment, containers, and utensils used to convey, hold, or store food in a manner that protects against contamination, to comply with 21 CFR 110.80(b)(7).   FDA investigators observed the following:
 
More specifically, an accumulation of filth and residue was observed on the raw pita dough conveyor belt; missing bristles and an accumulation of food debris on a brush being used to apply oil onto bagel dough; accumulation of filth and food residue on the pita conveyor used to transport finished pita bread to the packaging room, scoops used in dry material bins, wooden trays used as food contact surfaces, and on screws within the seed grinder; and the bread loaf pans were observed to be rusted with debris and constructed of seams that were not smoothly bonded.
 
4.    You must construct the plant and facilities in such a manner that floors, walls, and ceilings may be kept adequately cleaned and kept clean and in good repair as required by 21 CFR 110.20(b)(4). Specifically, your floors within the grinding room were observed to be partially made of wood and were not constructed of a smooth surface that can be adequately cleaned and sanitized.
 
It was also observed during the inspection, that two white buckets of what appeared to be pieces of old breads in the processing area, including the observation of an employee taking a bite of a piece of pita bread and then throwing the piece into the white bucket. The firm stated to the investigator that these buckets were designated for the trash; however you questioned the investigator about good manufacturing practices and (b)(4) to old product and using this as starter material for new product. Please note this practice is not in accordance with good manufacturing practice, and should not be implemented.
 
Misbranding
 
1.    Your Millet & Flax Italian Bread and Gluten Free Almond Biscotti products are misbranded within the meaning of Section 403(q) of the Act [21 U.S. C.343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example:
 
Millet & Flax Italian Bread
  • The product declares 126 Calories; however, caloric content per serving should be expressed in 10-calorie increment above 50 calories, in accordance with 21 CFR 101.9(c)(l).
  • The product declares 18 calories from fat; however, caloric content from fat should be expressed in the nearest 5 calorie increment up to and including 50 calories, in accordance with 21 CFR 101.9(c)(l)(ii).
  • The product fails to declare vitamins and minerals as required by 21 CFR 101.9(c)(8) and include a footnote as required by 21 CFR 101.9(d)(9).
  • The Nutrition Facts panel is not in the correct format as required by 21 CFR 101.9(d). Examples of formatting issues include headings, hairlines, bars, bolding, and rounding of nutrients. For example: Calories, Total Fat, Cholesterol, Sodium, Total Carbohydrates and Protein are not in bold type. Trans Fat, Dietary Fiber, and Sugars are not indented. The type size of the heading “Nutrition Facts” is incorrect and not bolded. The % Daily Value (DV) for nutrients is not listed.
Gluten Free Almond Biscotti
  • The “Servings Per Container” is incorrectly declared as “Serving Per Container” and express as “3ox” instead of the number of servings per container, which would be “3” in this case. (21 CFR 101.9(d)(3)(ii))
  • “Fat Calories” is not the appropriate abbreviation for “Calories from fat” and the use of abbreviations such as “Fat cal” and “Total carb” are only available for use in packages of 40 or less square inches in accordance with 21 CFR 101.9(j)(12)(ii)(B)). The product package appears to be greater than this size based on the labeled net weight.
  • The product declares 97 Calories; however, caloric content per serving should be expressed in 10 calories increments above 50 calories, in accordance with 21 CFR 101.9(c)(1).
  • The product declares 9 calories from fat; however, a caloric content from fat should be expressed in the nearest 5 calorie increment up to and including 50 calories, in accordance with 21 CFR 101.9(c)(1)(ii).
  • The Nutrition Facts panel is not in the correct format as required by 21 CFR 101.9(d). Examples of formatting issues include headings, hairlines and bars. Specifically, the use of heavy and light bars to separate terms from each other is missing on the current label. Calories, Total Fat, Cholesterol, Sodium, Total Carbohydrates and Protein are not in bold type. The type size of the heading “Nutrition Facts” is incorrect and not bolded. The % Daily Value (DV) for nutrients is not listed. 
2.    Your Millet & Flax Italian Bread and Gluten Free Almond Biscotti products are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S. C.343(i)(2)] in that they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4(b)(2). For example:
 
Millet & Flax Italian Bread
  • Aluminum Free Baking Powder and Italian Seasoning are multi-component foods, but the product fails to declare the sub-ingredients for these two foods.
Gluten Free Almond Biscotti
  • Aluminum Free Baking Powder is multi-component food, but the product fails to declare the sub-ingredients for this food.
In addition, we have the following comments regarding your product labels:
 
1.      “Millet Sourdough Bread”
  • The net weight is not declared in accordance with 21 CFR 101.105(j)(1) in that it does not declare the net weight in pounds in addition to the ounces. Additionally, it should be followed by the metric equivalent in parenthesis, 15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act.
  • The product declares 81 Calories; however, caloric content per serving should be expressed in 10-calorie increment above 50 calories, in accordance with 21 CFR 101.9(c)(l).
  • The product declares 9 calories from fat; however, caloric content from fat should be expressed in the nearest 5 calorie increment up to and including 50 calories, in accordance with 21 CFR 101.9(c)(l)(ii).
  • The abbreviation “Cal. from Fat” is only available for use in packages of 40 or less square inches (21 CFR 101.9(j)(13)(ii)(A)). The product package appears to be greater than this size based on the labeled net weight.
  • The statement of the place of business on the product label does not include the street address of the firm. According to 21 CFR 101.5(d), the statement of the place of business must include the street address, unless the street address is shown in a current city directory or telephone directory.
  • The label declares “Contains Gluten, Wheat, or Yeast.” Under FALCPA, if a “Contains” statement is included on a food label, the statement must identify the names of the food sources for all major food allergens that either are in the food or are contained in ingredients of the food; this would include incidental additives. We question the intent of the use of the term “or” in this “Contains” statement. Furthermore, gluten and yeast are not considered major food allergens. Based on the ingredient list, there does not appear to be any obvious sources of gluten, wheat or yeast ingredients, but based on the gluten analysis, the product appears to contain more than just incidental amounts of gluten. In addition, if gluten or wheat containing ingredient(s) are added ingredients in the manufacturing of the product, the ingredient(s) must be declared as part of the ingredient statement in accordance with 21 CFR 101.4.
2.      “Millet & Flax Italian Bread”
  • The net weight is not declared in accordance with 21 CFR 101.105(j)(1) in that it does not declare the net weight in pounds in addition to ounces. Additionally, it should be followed by the metric equivalent in parenthesis, 15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act.
  • In addition, we note that “Sugars” is declared incorrectly as “Sugar.” (21 CFR 101.9(c)(6)(ii)) 
3.      “Gluten Free Almond Biscotti”
  • The net weight should be followed by the metric equivalent in parenthesis, 15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act.
  • “Sugars” is incorrectly declared as “Sugar.” 21 CFR 101.9(c)(6)(ii)
  • “Protein” is misspelled as “Protein.” (21 CFR 101.9(c)(7))
  • Vitamins and minerals are not declared as required by 21 CFR 101.9(c)(8).
  • A footnote is not included as required by 21 CFR 101.9(d)(9).
  • We also note that in the ingredient statement, there should be a comma separating the “Almonds” and “Sunflower Seed Oil” ingredients, and the ingredient “Eggs” is listed twice.
4.      As you may already know, FDA finalized new requirements for nutrition labeling on May 27, 2016. The new Nutrition Facts label includes updates to the required nutrient declarations and formatting requirements.
 
Although, the compliance date will be July 26, 2018 or July 26, 2019 (depending on the size of the manufacturer), manufacturers may begin revising labels now to meet the new requirements. For more information on the new requirements, please see http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm
 
This is not an all-inclusive list of deficiencies in your product labeling. In response to this letter, please provide revised copies of your firm’s finished product labeling. 
 
We are providing the following link as a resource for assisting you in compliance with Act.
 
 
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable regulations. You should take prompt action to correct the violations described above and prevent their recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, including but not limited to, seizure and/or injunction against the manufacturers and distributors of violative products.
 
Further, 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.  A re-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 the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B).  For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic 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 notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
 
Your written response should be sent to Randall Morris, Compliance Officer at 555 Winderley Place, Suite 200, Maitland FL, 32751. If you have any questions about this letter, please contact Mr. Morris at 407-475-4741 or email him Randall.morris@fda.hhs.gov
 
 
Sincerely,
/S/ 
Susan M. Turcovski
Director, Florida District
 

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