Inspections, Compliance, Enforcement, and Criminal Investigations
Panaderia El Angel 4/5/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
April 5, 2012
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 12-20
Manuela E. Angel, Owner
Panaderia El Angel
102 West 5th Street
Arlington, Washington 98223-1268
Dear Ms. Angel:
On November 29, 30, 2011 and December 2, 7, 8, and 9, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your Hispanic bakery operation located at 102 West 5th Street, Arlington, Washington. During the inspection, the FDA investigators documented serious violations of the 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 food products produced in your facility to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and its implementing regulations on the Internet through links on FDA's web page at www.fda.gov.
Your significant violations include:
1. You failed to take precautions to ensure that production procedures do not contribute contamination from any source, as required by 21 CFR 110.80. Specifically,
a. The wood processing table is used to process allergen-containing products and non-allergen-containing products. There is no sequencing of products to prevent cross-contamination of products, nor is the table cleaned in between production of products.
b. On November 29, 2011, an unlabeled metal container of sliced nuts was observed on the shelf located adjacent to the south wall of the production area. One employee identified the nuts as sliced almonds, however, the baker identified the nuts as sliced walnuts.
c. On November 29 and 30, 2011, pastries containing egg and/or coconut were stored in direct contact with non-egg and/or non-coconut containing pastries on trays in the packaging area.
2. You failed to maintain equipment and utensils in an acceptable condition through appropriate cleaning and sanitizing, as required by 21 CFR 110.80(b)(l). Specifically,
a. On November 29 and 30, 2011, uncovered finished product in the finished product storage area was observed on metal pans containing white, brown and blackened flaking food residue. In addition, uncovered finished products were observed being held within ten inches underneath the brown and blackened food residue.
b. On November 30, 2011, brown food residue and grime was observed on the finished product shelving unit located in the retail/finished product storage area. Uncovered finished pastries were being held approximately ten inches underneath the brown food residue and grime.
c. On November 30, 2011, food residue and dried dough material was observed on (b)(4) that were last used the previous day and were ready to be used for current production. The (b)(4) mixer located along the northwest wall of the production area was later observed to be utilized to mix dough for the production of conchas without being further cleaned and sanitized.
d. On November 30, 2011, brown residue and dried dough material were observed on a (b)(4) dough divider that was last used the previous day, however, was ready to be used for current production. The dough divider was later observed to be utilized to divide dough for production without being further cleaned and sanitized.
e. On November 30, 2011, an employee was observed cleaning utensils, including a metal paddle and a metal spatula, in the three compartment sink without using a cleaning agent or sanitizer. Food residue was observed on the metal paddle after cleaning.
f. On November 29 and 30, 2011, brown and blackened food residue was observed on the mobile racks located in the production area, the finished products storage area, and inside of the walk-in cooler. Uncovered finished product and/or dough were stored on each of the racks.
g. On November 30, 2011, one cleaned scoop and one cleaned pie and cake slice marker were observed in direct contact with food residue and grime located on the white drying rack used to drain cleaned utensils in the production area.
3. You failed to take effective measures to protect finished food from contamination by raw materials and other ingredients, as required by 21 CFR Part 110.80(b)(6). Specifically,
a. On November 29 and 30, 2011, uncovered finished products were observed being held in the raw ingredient storage area located in the northwest comer of the facility. In addition, uncovered finished products (mantecada pastries) were observed in direct contact with the outer surface of a bag of flour. The outer surface of the flour bag appeared to contain dirt and dust particles.
4. You failed to handle work-in-progress in a manner that protects against contamination, as required by 21 CFR Part 110.80(b)(5). Specifically,
a. On November 29, 2011, a metal pan with brown flaking food residue was observed in direct contact with uncovered in-process products stored in the walkin cooler. In addition, metal pans were observed being stored on non-food contact surface material throughout the facility.
b. On November 30, 2011, uncovered dough was observed in direct contact with brown flaking residue on the metal pans located inside the walk-in cooler.
5. You failed to store raw materials in a manner that protects against contamination, as required by 21 CFR 110.80(a)(1). Specifically,
a. On November 30, 2011, dried blackened flaking residue was observed in the flour. In addition, dried dough material and food residue was observed on the exterior surfaces of a storage bin containing flour.
b. On November 30, 2011, dried blackened flaking residue was observed in the powdered sugar. In addition, dried dough material and food residue were observed on the interior and exterior surfaces of a storage bin containing powdered sugar.
6. You failed to have employees wash and sanitize hands thoroughly in an adequate handwashing facility after each absence from the work station and each time their hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3). Specifically,
a. On November 29, 2011, a production employee was observed returning to his work station and shaping dough for oreja pastries without washing his hands after contacting the bottom part of a metal pan that was stored on top of bags of flour.
b. On November 29, 2011, a production employee was observed scraping blackened residue from a baking sheet with his hands and then using his bare hands to shape dough for torta breads without washing his hands.
c. On November 30, 2011, a production employee was observed scraping food residue from the wood processing table with his hands and then, without washing his hands, observed using his bare hands to shape dough for the production of torta breads.
d. On November 30, 2011, a production employee was observed shaping dough for torta breads without washing his hands after contacting surfaces of the three compartment sink used for cleaning equipment and utensils and rinsing his hands with only water.
7. You failed to have employees remove hand jewelry which cannot be adequately sanitized during periods where food is being manipulated by hand, as required by 21 CFR 110.10(b)(4). Specifically,
a. On November 29, 2011, a production employee shaping dough in the prep area was observed directly contacting the dough with bare hands while wearing a cloth bracelet. The bracelet was observed in direct contact with the dough used for the production of oreja pastries.
8. You failed to maintain buildings, fixtures, or other physical facilities in a sanitary condition, as required by 21 CFR 110.35(a). Specifically,
a. On November 29 and 30, 2011, loose-fitting or missing ceiling tiles were observed in the production and finished product storage areas. One ceiling tile was observed missing above uncovered finished products in the packaging and storage area, five ceiling tiles were observed missing above the oven located in the southwest corner of the production area and adjacent to one rack containing uncovered finished products, and one loose-fitting ceiling tile was observed above the dough sheeter located along the south wall of the production area.
b. On November 29 and 30, 2011, cracked or missing black and white floor tiles were observed in the finished product and raw ingredient storage area adjacent to the door leading into the production area. Food debris and grime were observed on the floor surrounding this area. Uncovered finished pastries were stored within one foot of this area. Th mixer positioned along the northwest wall of the production area was being used to process uncovered dough and was located approximately three feet of this area as well.
c. On November 30, 2011, an approximate two inch wide gap was observed along the south wall in the southeast corner of the production area. The gap was located between the bread proofer and the walk-in cooler. Spider webs were observed along the gap. Uncovered in-process product was observed stored approximately three feet from the spider webs.
We acknowledge that during the course of the inspection, you corrected some of the issues listed above, and promised to correct the remaining issues. However, we have not received a written response from you providing us with evidence of your corrective actions.
In addition to the sanitation issues listed above, labels were collected and reviewed during the inspection. A review of the labels revealed that your Pastel 3 Leches is misbranded within the meaning of section 403 of 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 110 (21 CFR part 110).
1. Your Pastel 3 Leches product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the label fails to declare the major food allergen in the product, as required by section 403(w)(1). Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines as major food allergens milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of those foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:
a. The word "Contains," followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients [section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)], or
b. The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source which the major food allergen is derived, except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list, appears as part of the name of the ingredient list, appears as part of the name of an ingredient that is not a major food allergen) (section 403(w)(1)(B) of the Act [21 U.S.C. 343(w)(1)(B)].
Wheat: Your Pastel 3 Leches is manufactured with enriched wheat flour but you fail to declare the major food allergen, wheat.
Tree Nuts: Your Pastel 3 Leches (walnut variety) fails to declare walnuts on the product label.
We note that your Pastel 3 Leches product contains soybean oil, which may contain the major food allergen, soy. If the soybean oil is not highly refined, the allergen source material, soy, must be declared on your finished product label.
2. Your Pastel 3 Leches product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]in that the label fails to declare the common or usual name of each ingredient in the product as required per 21 CFR 101.4(a). For example:
a. Your Pastel 3 Leches product lists the terms "Royal, Chantilli, Oil" on the finished product label, but these terms are not the common or usual name of these ingredients. Specifically, oil must identify the source, which is soybean
b. Your Pastel 3 Leches product contain ingredients, and/or sub-ingredients that are not declared on the finished product label in accordance with 21 CFR 101.4(b)(2). Specifically, enriched wheat flour (wheat flour, malted barley flour, enriched with niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), modified food starch, dough conditioner and artificial flavor.
3. Your Pastel 3 Leches product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that it fails to declare the net weight of the product as required per 21 CFR 101.105(e).
4. Your Pastel 3 Leches product is misbranded with the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because your product label contains information in two languages but does not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
During our review we also noted these additional observations:
1. It appears that you are using one label for all six varieties of your Pastel 3 Leches product; walnut, coconut, creme custard, peach, pineapple and strawberry. As it is, your current label does not capture the ingredients used in the product accurately. If you wish to use one label for all six products, a "Catch-All" or "Shotgun" ingredient declaration may be used [see CPG Sec. 505.100@ http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074420.htm].
2. The general statement of identity, Pastel 3 Leches, does not indicate to the consumer the different varieties of cake.
3. Your product label declares "conservatives." Based on a discussion during the inspection, these are actually preservatives (i.e. sodium metabisulfite). If there are preservatives present in significant amounts, they must be declared in accordance with 21 CFR 101.22G).
We acknowledge that you voluntarily recalled the strawberry cakes product due to undeclared wheat and various pastries and cookies due to undeclared Red #3. During the close-out discussion with our investigator, you stated that you would have new labels created to correct label deficiencies within one month of the inspection. Please be advised that in addition to declaring the proper ingredients, the new labels must correct all deficiencies listed above.
The above is not intended to be an all-inclusive list of violations. You are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law. You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action such as seizure and/or injunction without further notice.
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 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.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. 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 fifteen (15) working days of receiving this letter, 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 Farhana Khan, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4426. If you have any questions about this letter, please contact Compliance Officer Farhana Khan at 425-483-4968.
Charles M. Breen
cc: Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560