Inspections, Compliance, Enforcement, and Criminal Investigations
JFD Enterprises Inc., 12/14/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
RETURN RECEIPT REQUESTED
Mr. Santos A. Sanchez, Owner
JFD Enterprises Inc. t/a Antonio's Bakery
6210 Eastern Avenue
Baltimore, MD 21224
Dear Mr. Sanchez:
The Food and Drug Administration (FDA) conducted an inspection of your bakery, located at 6210 Eastern Avenue, Baltimore, Maryland on July 15-17,21 and August 4, 2009. During the inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulations for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 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. Additionally, our review of other evidence collected during the inspection has determined that your products are 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 21 CFR Part 101. You can find the Act and the FDA regulations through links in FDA's homepage at www.fda.gov.
Violations of Current Good Manufacturing Practice Regulations
1. As required by 21 CFR 110.35(c), no pests shall be allowed in any area of a food plant. Effective measures must be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. However, our investigators observed the following evidence of a lack of pest control during the inspection:
a. Live cockroaches were observed crawling throughout the facility including:
i. On the rolling racks used to transport uncooked bread dough from the proofer to the oven; and,
ii.. In the front area of your facility where the finished bread, buns and rolls are packaged and stored.
b. Live insects were found in opened containers of raw ingredients used in the manufacture and processing of bread, buns and rolls including:
i. In a large opened bag of poppy seeds;
ii. In a bin of sesame seeds;
iii. In a container of dough conditioning material; and,
iv. In a container of shortening.
c. Dead insects were observed throughout the facility including:
i. A dead cockroach inside of a mixing bowl;
ii. A dead cockroach underneath the 3-compartment sink in the cleaning room;
iii. 20 small dead insects in cornmeal that had spilled onto the floor in the oven room.
d. A live mouse was observed in a mouse trap in the oven room.
e. Open doors and unscreened open windows offering easy entry to pests into your bakery. Further, as required by 21 CFR 110.20(b)(7), you must provide adequate screening or other protection against pests.
2. As required by 21 CFR 110.20(b)(1), you must provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food. However, our investigators observed the following during the inspection:
a. Unused manufacturing equipment and supplies stored throughout the facility, including in the food processing area and the oven room;
b. The floor area between the oven and adjacent wall contained trash and debris; and,
c. The storage of uncovered trash cans directly underneath equipment used in the manufacturing and processing of raw dough.
3. As required by 21 CFR 110.80(a)(7), you must hold all liquid or dry raw materials and other ingredients received and stored in bulk form in a manner that protects against contamination.
However, our investigators observed the following during the inspection:
a. An opened bag of flour was stored on a table in the processing room. This bag was stored directly on top of unopened bags of flour;
b. An open pan containing a white powder was stored underneath a table in the processing room;
c. An uncovered bowl of whipped cream was stored on the bottom shelf of the refrigerator; and,
d. An opened and uncovered stick of butter was stored directly on a shelf in the refrigerator.
4. As required by 21 CFR 110.80(b)(1), you must maintain all equipment, utensils, and finished food containers in an acceptable condition through appropriate cleaning and sanitizing, as necessary. However, our investigators observed the following during the inspection:
a. An accumulation of dirt and other debris on the top of the compressor; and,
b. An accumulation of dried dough residue and flour on the underside of the spiral mixer used by the firm.
In addition, as required by 21 CFR 110.35(d), you must clean all food-contact surfaces, including utensils and food-contact surfaces of equipment, as frequently as necessary to protect against the contamination of food. However, our investigators observed the following during the inspection:
a. An accumulation of dried dough and flour on the metal scoop used to measure out raw ingredients;
b. An accumulation of dried dough and flour on the inside of the plastic bin used to mix dough; and,
c. An accumulation of old dough residue on the interior of the divider and on the interior of the metal compartments in the compressor.
5. As required by 21 CFR 110.40(a), all equipment and utensils must be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils must preclude the adulteration of food with any contaminants. However, our investigators observed the following during the inspection:
a. The wooden workbench used to roll out dough was observed to have cracks, gouges and holes. Moreover, several of the cracks and holes contained old dough and other unidentified debris.
1. Your bakery products sold to individual customers are misbranded within the meaning of section 403(w)(1) of the Act [21 U.S.C. § 343(w)(1)] in that their labels fail to declare all major food allergens present in the products.
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 containing proteins derived from one of these 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:
• 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
• 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 from which the major food allergen is derived, except that 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 an ingredient that is not a major food allergen) [section 403(w)(1)(8) of the Act; 21 U.S.C. § 343(w)(1)(8)].
Specifically, your dough is made with the raw material "high gluten flour," which is a wheat based flour, but your dough-based products fail to declare the presence of the major food allergen "wheat" on the label.
2. Your bakery products sold to individual customers are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients and the labels fail to declare the common or usual name of each ingredient as required under 21 CFR 101.4.
3. Your bakery products sold to individual customers are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because their labels fail to bear the common or usual name of the food as required under 21 CFR 101.3.
4. Your bakery products sold to individual customers are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] for failing to bear a label containing the name and place of business of the manufacturer, packer, or distributor as required under 21 CFR 101.5(a).
5. Your bakery products sold to individual customers are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] for failing to bear a label containing an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count as required under 21 CFR 101.105(a).
This letter may not list all the deviations at your facility. You are responsible for ensuring that your bakery operates in compliance with the Act, the CGMP regulations (21 CFR Part 110), and the Food Labeling regulations (21 CFR Part 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
The specific violations noted in this letter may be symptomatic of serious problems in your firm's CGMPs. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please direct your response to: Anne Aberdeen, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101 Baltimore, MD 21215. If you have any questions, please contact Ms. Aberdeen at (410) 779-5134.