WARNING LETTER
Vaccaro's Italian Pastry Shop, Inc.
MARCS-CMS 577001 —
June 12, 2019
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Maria R. Vaccaro
Recipient Title
Co-Owner
Vaccaro's Italian Pastry Shop, Inc.
3705 East Baltimore Street
Baltimore
,
MD
21224
United States
Issuing Office:
Division of Human and Animal Food Operations East II
United States
June 12, 2019
WARNING LETTER
CMS: 577001
Dear Ms. Vaccaro:
The U.S. Food and Drug Administration (FDA) inspected your bakery facility, located at 3705 East Baltimore Street, Baltimore, MD, from December 7, 2018 to March 1, 2019. The inspection covered your Ready-to-Eat (RTE) bakery products and revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule in Title 21, Code of Regulations Part 117 (21 CFR 117) (CGMP & PC rule).
Based on FDA's inspectional findings observed during the inspection, we determined that food manufactured in your facility is 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 it was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by Section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links in FDA's Internet home page at
http://www.fda.gov.
FDA's inspection resulted in issuance of an FDA Form-483 (FDA-483), Inspectional Observations, listing deviations found during our inspection. We are issuing this letter to advise you of FDA's concerns and provide detailed information describing the findings at your facility. We acknowledge your responses to the FDA-483, provided both verbally post inspection on March 27, 2019 and in a written response dated March 14, 2019, describing corrective actions taken by your firm. There is currently insufficient information for the Agency to evaluate the adequacy of your described corrective actions.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
The CGMP & PC rule creates new requirements for covered facilities to perform a hazard analysis and establish and implement risk-based preventive controls for human food. The CGMP & PC rule provides that you must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control [21 CFR § 117.130(a)]. The CGMP & PC rule further provides that you must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under Section 402 of the Act or misbranded under Section 403(w) of the Act [21 CFR § 117.135(a)(1)].
Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135). Preventive controls are subject to preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140).
The CGMP & PC rule requires a food safety plan (21 CFR § 117 .126), which must include the following:
(1) The written hazard analysis, as required by§ 117.130(a)(2);
(2) The written preventive controls, as required by§ 117.135(b);
(3) The written supply-chain program, as required by subpart G;
(4) The written recall plan, as required by § 117.139(a);
(5) The written procedures for monitoring the implementation of the preventive controls, as required by§ 117.145(a)(l);
(6) The written corrective action procedures, as required by§ 117.150(a)(1); and
(7) The written verification procedures, as required by § 117. l 65(b).
1. You did not prepare, or have prepared, and did not implement a food safety plan for the food products manufactured in your facility (including macaroons, other cookies, and cakes), as required by 21 CFR § 117.126(a)(1). Your food products may have biological, chemical, and physical hazards which could require process, allergen, sanitation, and supplier controls.
In your written response, you indicate that you
(b)(4)
.
2. You did not conduct a hazard analysis for any of your products to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR § 117.130(a). Specifically,
a. You did not identify allergen cross-contact as a known or reasonably foreseeable hazard to determine whether it is as a hazard requiring a preventive control. Your facility manufactures various products with different allergen profiles on the same day and on shared equipment.
b. You did not identify vegetative pathogens, such as pathogenic
Escherichia coli
and/or
Salmonella
, as a known or reasonably foreseeable hazard to determine whether vegetative pathogens are a hazard requiring a preventive control. Your facility manufactures various products with wheat flour and/or tree nuts (such as pine nut macaroons and almond macaroons). These ingredients have been associated with pathogens.
c. You did not identify mycotoxins as a known or reasonably foreseeable hazard to determine whether mycotoxins are a hazard requiring a preventive control. Your facility manufactures various products with wheat flour and/or tree nuts (such as pine nut macaroons and almond macaroons). These ingredients have been associated with mycotoxins.
d. You did not evaluate environmental pathogens, such as
Listeria monocytogenes
and
Salmonella
, as part of a hazard evaluation to assess the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls, to comply with 21 CFR § 117.130(c)(1)(ii). Specifically, your facility manufactures RTE food which is exposed to the environment prior to packaging.
(b)(4)
.
3. You did not identify and implement preventive controls for any of your products to provide assurance that any hazards requiring a preventive control will be significantly minimized or prevented, as required by 21 CFR § 117.135(a). In addition, you did not establish and implement written procedures for monitoring, written corrective action procedures, or conduct verification activities, as required by 21 CFR §§ 117.140-117.165.
Current Good Manufacturing Practice (Subpart B):
4. You did not clean your non-food contact surfaces in a manner and as frequently as necessary to protect against contamination and against allergen cross-contact, as required by 21 CFR § 117.35(e). Specifically,
a. Your production routinely
(b)(4)
, or otherwise considering the potential for unintentional transfer of allergenic protein from a product formulated with an allergen to a product not formulated with that allergen. Specifically,
(b)(4)
; it is not replaced when a new allergen is introduced into production that day (such as when switching from macaroons containing pine nuts to macaroons not containing pine nuts). In addition,
(b)(4)
.
b. Employees were observed removing pine nut pignoli macaroons from cookie sheets and placing them on a baking sheet at a work station. The employees then worked with sliced almond macaroons in the same area without cleaning pignoli macaroon debris from the work station.
5. You did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR § 117.35(c). Specifically, apparent rodent excreta pellets too-numerous-to-count were observed during the inspection in multiple sections of the room where baked products are packaged. For example, apparent rodent excreta pellets were observed on pallets of pizzelle waffle cookies and lady finger cookies, under a pallet of lady finger cookies, and behind a pallet at the entrance of the packaging room. Also, apparent nesting material was observed under a pallet of pizzella waffle cookies.
6. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials did not conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR § 117.10(b). Specifically,
a. An employee's bare arm (a potential route of contamination) was observed touching RTE macaroons while removing them from a sheet after baking.
b. An employee with a beard was observed mixing custard in the production area without wearing a beard restraint.
Misbranding Charges
7. Your Rum Cake, Cassata Cake, Chocolate Cassata Cake, Chocolate Hazelnut Cake, retail and internet platters, and Cookies in Tins products are misbranded within the meaning of Section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergens wheat, egg, milk and in some cases almonds and hazelnuts, as required by section 403(w)(l) of the Act. Specifically, your products are formulated to be manufactured using
(b)(4)
. None of the cakes or platters are labeled with an ingredient statement.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils as "major food allergens." A food is misbranded under section 403(w) of the Act ifit 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)(l)(A) of the Act [21 U.S.C. § 343(w)(l)(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 (e.g., "Whey (Milk)"), 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 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)].
Further, for your Cookies in Tins, the terms "Major Allergens," "tree nuts," and "pignoli nuts" do not meet the requirements of section 403(w) of the Act. The term "pignoli nuts" is not recognized as a synonym for the term "pine nuts." Furthermore, we question whether
(b)(4)
.
8. Your Rum Cake, Cassata Cake, Chocolate Cassata Cake, Chocolate Hazelnut Cake, Regular and Chocolate Cannoli, retail and internet "platters," as well as all Cookies in Tins products are misbranded within the meaning of section 403(i)(l) of the Act [21 U.S.C. §343(i)(l)] in that the product labels fail to bear the common or usual name of the food. For example, the product label fails to declare a statement of identity of the food as required by 21 CFR 101.3.
9. Your Rum Cake, Cassata Cake, Chocolate Cassata Cake, Chocolate Hazelnut Cake, retail and wholesale Regular and Chocolate Cannoli, retail and internet "platters," as well as all Cookies in Tins products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products
(b)(4)
, as required under 21 CFR 101.4. For example, according to your formulation sheet:
a. Your Rum Cake, Cassata Cake, Chocolate Cassata Cake, Chocolate Hazelnut Cake, and retail and internet "platters" products are not labeled with an ingredient statement as required by 21 CFR 101.4(a)(1).
b. Your retail Regular and Chocolate Cannoli are labeled with the same ingredient statement regardless of which product is represented and shows the following statement: "Whole Milk Ricotta (pasteurized whole milk, milk culture, salt) Coco Drops (partially hydrogenated palm kernel oil, Cocoa powder, Soya Lecithin) Bleached Wheat Flour, Wine Vinegar, Non-trans Fat Shortening (Palm Oil)."
o The Bleached Wheat Flour is enriched and includes the following ingredients which are not declared on your label:
(b)(4)
. [21 CFR 101.4(b)(2)]
o The sub ingredients for the "cocoa drops" ingredient on the Cannoli cream label do not agree with the sub ingredients of the Barry Callebaut Chips-Dark Chocolate Flavored Confectionery. [21 CFR 101.4(b)(2)]
o
(b)(4)
; therefore, "Bleached Wheat Flour" is not an appropriate common or usual name because it does not include "Enriched" or "Bromated" as part of the name [21 CFR 101.4(a)(1) and 137.160].
o "non trans fat shortening" is not part of the common or usual name of "palm oil" [21 CFR 101.4(a)(1) and (b)(14)].
o The Chocolate Dipped Cannoli shells are made with
(b)(4)
.
o The ingredient statement seems to represent cannoli made with regular cannoli cream and regular cannoli shells; however, it does not include the
(b)(4)
[21 CFR 101.4(a)(1)].
o Ingredient statements were not provided for varieties of cannoli made with
(b)(4)
[21 CFR 101.4(a)(1)].
c. Your bulk Regular and Chocolate Cannoli are labeled with the same ingredient statement regardless of which product is represented and shows the following statement for the Shells: "Bleached Wheat Flour, Wine Vinegar, Non-Trans Fat Shortening, Palm or Soy Oil), Sugar" and for the filling: "Whole Milk Ricotta (Pasteurized Whole Milk, Milk Culture, Salt), Sugar, Flavoring and Spices, Cocoa Drops (partially hydrogenated palm kernel oil, cocoa powder, soya lecithin, salt)."
o The sub ingredients for the "cocoa drops" ingredient on the Cannoli cream label do not agree with the sub ingredients of the Barry Callebaut Chips-Dark chocolate flavored confectionery label. [21 CFR 101.4(b)(2)]
o The Cannoli Shells are made with
(b)(4)
; therefore, "Bleached Wheat Flour" is not an appropriate common or usual name because it does not include "Enriched" or "Bromated" as part of the name [21 CFR 101.4(a)(1) and 137.160].
o "
(b)(4)
" is not part of the common or usual name of "
(b)(4)
" [21 CFR 101.4(a)(l) and (b)(14)].
o The Bleached Wheat Flour is enriched and includes the following ingredients which are not declared on your label:
(b)(4)
. [21 CFR 101.4(b)(2)]
o The Cannoli Shells package includes a check off list which indicates that this package may also be used for
(b)(4)
; however, an ingredient label is not provided for this option [21 CFR 101.4(a)(1)].
d. Your Cookies in Tins are all labeled with the same ingredient statement which is further identified as "(May Contain)."
o There is no provision in 21 CFR 101.4 for use of "May contain" for the ingredient list.
o "Flour" is not the appropriate common or usual name for the '"flour" ingredient(s) used in the foods.
(b)(4)
ingredients are used for the products that may be included in the tins. The macaroons are made with
(b)(4)
and the Cookies are made with
(b)(4)
[21 CFR 101.4(a)(1)].
o "
(b)(4)
" is not an appropriate common or usual name for a
(b)(4)
[21 CFR 101.4(a)(1)].
o Ingredients are not declared for the candies that are included in the tins [21 CFR 101.4(a)(1)].
o All macaroons are
(b)(4)
.
o All macaroons are further manufactured using the ingredient,
(b)(4)
listed in the ingredient statement.
o
(b)(4)
, are not declared on the label.
o All cookies are formulated to contain "
(b)(4)
are not listed in the same descending order of predominance.
o
(b)(4)
require that their sub ingredients be listed in the ingredient statement.
The above listing of ingredients is not an exhaustive listing of ingredients which are themselves comprised of multiple ingredients requiring declaration.
According to 21 CFR 101.4(b)(2), the requirement to list component ingredients (or "sub ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
10. Your Rum Cake, Cassata Cake, Chocolate Cassata Cake, Chocolate Hazelnut Cake, retail and wholesale Regular and Chocolate Cannoli, retail and internet "platters," as well as all cookies in tins products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the labels fail to have nutrition facts labels as defined in 21 CFR 101.9. Based on the number of employees, it is possible that some of your products may qualify for the Small Business Nutritional Labeling Exemption (SBNLE) in 21 CFR 101.90)(18); however, we have no record you having filed a notice for the SBNLE as required in this section.
11. Your Cookies in Tins, Cassata cakes (regular and Chocolate) and Hazelnut Butter Creme Cake products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the products contain artificial coloring and chemical preservatives but fail to bear labeling stating that fact. Specifically:
a. Your Cookies in Tins and Cassata cakes (regular and Chocolate) products are, in part, manufactured with
(b)(4)
; however, the products do not bear a label identifying the presence of these
(b)(4)
using their listed names or appropriate abbreviations, as required under 21 CFR 101.22(k)(l).
b. Many of the raw material ingredients in your Cookies in Tins, Cassata cakes (regular and Chocolate), and Hazelnut Butter Creme Cake products contain chemical preservatives; however, no preservatives are declared on any of the ingredient labels as required in 21 CFR 101.22(j). For example, the
(b)(4)
cookies and Cassata Cakes contain
(b)(4)
.
12. Your Rum Cake, Cassata Cake, Chocolate Cassata Cake, Chocolate Hazelnut Cake, retail Regular and Chocolate Cannoli, retail and internet "platters," as well as all Cookies in Tins products are misbranded within the meaning of section 403(e)(l) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).
13. Your Rum Cake, Cassata Cake, Chocolate Cassata Cake, Chocolate Hazelnut Cake, Regular and Chocolate Cannoli, retail and internet "platters," as well as all Cookies in Tins products are misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear an accurate statement of the net quantity of contents in terms of weight as required by 21 CFR 101.7.
Color Adulteration Charge
14. Your Cookies in Tins product is adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because the product bears or contains a
(b)(4)
which is unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379e(a)]. Section 721(a) deems a
(b)(4)
to be unsafe unless its use is in conformity with the
(b)(4)
listing regulation. Specifically, the listing regulation for
(b)(4)
requires that the
(b)(4)
be listed by that name in the ingredient list on the labels of foods for human use (21 CFR 74.705(d)(2)]. Your product is manufactured, in part, with
(b)(4)
in the ingredient statement.
We also offer the following comments regarding your labels:
• It is not clear whether the Chocolate Cream Cannoli is also shipped in the Cannoli Cream wholesale package. If these bulk packages are used for other Cannoli varieties, ingredient labels must be provided for those as well.
• It appears that you are attempting to use a "Catch-All" or "Shotgun" ingredients declaration for your Cookies in Tins; however, you are not doing it correctly. We refer you to CPG Sec. 505.100 Bakery Products, Candy - "Catch-All" or "Shotgun" Ingredients Declaration for the correct way to create one ingredient statement that can be used for multiple products:
https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074420.htm
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.
Section 743 of the Act, (21 USC 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 non-compliance 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 USC 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 non-compliance 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 of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including revised procedures, photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Your written response should be sent to Matthew R. Noonan, Compliance Officer, United States Food & Drug Administration, Human & Animal Food Division II East, Philadelphia District Office, U.S. Custom House, Room 900, 200 Chestnut Street, Philadelphia, PA 19106. If you have any questions, please contact Mr. Noonan at the above physical address, by phone at
(215) 717-3074
, or by email at matthew.noonan@fda.hhs.gov.
Sincerely,
/S/
Evelyn Bonnin
Program Division Director
District Director
Human & Animal Food Division II East
Baltimore District Office
Cc: Maryland Department of Health
Robin Henderson PhD, RD/LDN
Chief, Center for Food Processing
DHMH/PPHA Environmental Health Bureau
6 St. Paul Street, Suite 1301
Baltimore, MD 21202
Content current as of:
06/25/2019
Regulated Product(s)
Food & Beverages