| Public Health Service Food and Drug Administration |
Central Region Waterview Corporate Center |
Department of Health and Human ServicesSeptember 8, 2011
WARNING LETTER
VIA UPS OVERNIGHT
Mr. Shraga Zabludovsky
President
Paramount Muffins, LLC
61 Davenport Avenue
Newark, New Jersey 07107-2533
File No.: 11-NWJ-23
Dear Mr. Zabludovsky:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility located at 61 Davenport Ave., Newark, NJ, on May 31, June 2-3, and June 10, 2011. The inspection revealed serious violations of FDA's Current Good Manufacturing Practice (CGMP) regulations for foods (21 CFR Part 110). These violations cause the food products produced at your facility, including muffins and cakes that you generally sell under the brand name "Sweet City," 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 have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and FDA's regulations through links on FDA's home page at http://www.fda.gov.
The inspection of your facility revealed the following violations of the CGMP regulation:
1. Your firm failed to handle work-in-process in a manner that protects against contamination, as required by 21 CFR 11 0.80(b)(5). Specifically, our investigators observed:
a. On 5/31/11, a baker's rack containing ten trays of ready-to-eat muffins and loaves was observed in an open doorway exposed to the street and to flies which were observed around the rack and landing on it, and to a filthy exhaust fan above the doorway. The filth on the exhaust fan appeared to be greasy build-up and fuzzy lint-like material.
b. On 5/31/11 and 6/2/11, a baker's rack containing trays of ready-to eat corn muffins (5/31/11) and loaves (6/2/11) was observed cooling under a fly strip which contained dead flies too numerous to count. The fly strip was being blown back and forth over the product by the air movement created by an exhaust fan approximately five feet away.
c. On 5/31/11, a mixing bowl loosely covered with plastic and containing icing for cakes and muffins was observed to be nested in a larger mixing bowl on a mixing stand. The mixer was observed to be heavily encrusted with product residue, and approximately 30 live insects were observed on the mixer directly above the bowl of icing and on the plastic covering the bowl of icing.
2. Your firm failed to take all reasonable measures and precautions to ensure that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against the contamination of food, as required by 21 CFR 110.10(b). Specifically:
a. Employees did not wash their hands thoroughly after each absence from the work station and at any time their hands may have become soiled or contaminated [21 CFR 110.10(b)(3)]. Specifically, on 6/2/11 our investigators observed the following sequence of events while observing production: an employee touched his bare hands on the rim of a hopper, scratched his nose, wiped his nose with his hand and shirt sleeve, then used both hands to remove loose chocolate chips from a box and proceeded to cover the tops of in-process muffins with the chocolate chips, and then continued to fill muffin pans using the air-actuated batter dispenser. At no time during this sequence of events did the employee wash and sanitize his hands or use gloves.
b. Employees failed to wear suitable outer garments that protect against contamination of food [21 CFR 110.10(b)(1)]. Specifically, a bakery employee was observed wearing heavily soiled street clothes while performing activities such as transferring batter from the mixer to the hopper, filling muffin and loaf pans, and loading and unloading ovens.
3. Your firm failed to provide adequate hand-washing facilities at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hands, as required by 21 CFR 110.37(e). Specifically, there was no hand-washing station in the production area and the lavatory sink lacked hot water.
4. Your firm failed to clean food-contact surfaces, including utensils and equipment, as frequently as necessary to protect against contamination of food, as required by 21 CFR 11 0.35(d). For example:
a. The packaging machine and conveyor system were observed to have peeling paint, food product residue and apparent rodent excreta pellets (REPs) present. In addition, the floor beneath the packaging machine had an abundance of food product residue and apparent REPs too numerous to count.
b. Equipment and utensils cleaned in the single-compartment sink were stored on dirty shelves that also contained employees personal food containers and chemicals, such as PVC cement and asphalt crack filler. Additionally, the purportedly cleaned utensils were observed to contain apparent product residue.
c. An apparent REP was present on plastic wrap stored on the frame of the packaging machine.
d. The finished product bin, adjacent to the packaging machine, contained parts of unwrapped finished product, food product residue, excess plastic wrap, and approximately ten apparent REPs in the lower tray.
5. Your firm failed to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination, as required by 21 CFR 110.35(d)(3). Specifically, our investigators observed a compressed air line directly over the hopper containing batter that appeared to be encrusted with food residue.
6. Your firm failed to store raw materials in a manner that protects against contamination, as required by 21 CFR 110.80(a)(1). Specifically, our investigators observed:
a. At least several dozen apparent REPs were observed on and around pallets containing bags of corn meal, cake base, and flour, with several apparent REPs on the bag themselves;
b. Numerous apparent REPs were observed on boxes of dry ingredients and on the shelves on which the boxes were stored;
c. Apparent grain beetles in and around the flour conveyor system adjacent to pallets of dry ingredients;
d. Spilled raw materials and machine oil on and around pallets of corn meal, cake base, and flour;
e. Flies in the facility around raw materials and the dump bin for the flour conveyor system;
f. Boxes and buckets of dry ingredients covered in filth;
g. Inner plastic bags of dry ingredients were not securely closed to prevent ingress of pests.
In addition, our investigators observed a cardboard box containing plastic wrap for packaging finished product stored on the damp floor of the raw material storage area. The box appeared to be moldy and covered with other filth.
7. Your firm failed to maintain physical facilities in repair in a sanitary condition and keep them in repair sufficient to prevent food from becoming adulterated, as required by 21 CFR 11 0.35(a). Specifically, our investigators observed:
a. A copper water pipe in the raw material basement storage area was corroded and leaking onto storage shelves, splashing pallets containing bags of flour, cake base, and corn meal.
b. The floor in the raw material basement storage area was pitted and the floor was wet in several areas with no apparent source of the moisture.
c. The ceiling in the manufacturing area was observed to have peeling paint, directly over baker's racks containing ready-to-eat product. Adjacent to the area where peeling paint was observed, a hole in the ceiling was stuffed with a dirty work glove.
d. An open pipe near the side doorway was stuffed with paper instead of being properly capped. On the first day of the inspection, ready to-eat product was observed cooling in this area.
8. Your firm failed to take effective measures to exclude pests from food processing areas, as required by 21 CFR 11 0.35(c). For example:
a. Apparent rodent excreta pellets (REPs) were observed in several areas of the facility, including on and around the packaging machine used to package ready-to-eat products, on and around a second packaging line not currently in use, in the multi-purpose processing room for ready-to-eat products, and on shelves and pallets in the raw material basement storage area. As noted earlier, an open box of chocolate chunks in the raw material storage area was stained and dirty and the inner bag and product had apparent rodent and insect contamination. Also, a broken bag of cake base in an open, stained, and dirty cardboard box was observed in the raw material storage area. The raw material contained insects, spiders, apparent REPs, hairs and other filth.
b. Flies were observed in the facility, and open, unscreened doors and windows were observed on every day of the inspection.
9. Your firm failed to provide adequate screening or otherwise protect against pests, as required by 21 CFR 110.20(b)(7). Specifically, the side doorway (N. 8th St.) had an approximate 1/2-inch gap at the bottom of the doorway.
10. Your firm failed to provide employees with adequate toilet facilities, as required by 21 CFR 11 0.37(d). Specifically, our investigators observed:
a. The floor of the men's lavatory, which was adjacent to the processing area, appeared to be wet and cardboard on the floor was also wet. The moisture appeared to be due to a leaking toilet.
b. The door to the men's lavatory opened directly to the processing area for ready-to-eat products and was not self-closing, remaining open unless manually closed.
11. Your firm failed to provide safety-type light bulbs or fixtures suspended over exposed food or to otherwise protect against food contamination in case of glass breakage, as required by 21 CFR 110.20(b)(5). Our investigators observed uncovered, fluorescent tube lighting that was without protective covering in areas of the facility where ready-to-eat food products are processed, such as in the areas of the mixers, batter hoppers, work tables and ovens.
12. Your firm failed to provide sufficient space for such placement of equipment and storage materials as is necessary for the maintenance of sanitary operations and the production of safe food, as required by 21 CFR 110.20(b)(1). Specifically, the aisles and working spaces between equipment and walls in the main bakery processing area were obstructed with boxes and packaging materials, in-process products, baker's racks, and both used and un-used equipment. These conditions impaired adequate cleaning and maintenance of the facility.
The above violations are not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure that all of your products are in compliance with the applicable requirements of the Act and FDA's implementing regulations.
You should take prompt action to correct the violations cited in this letter. Failure to correct the violations may result in regulatory action without further notice, such as seizure or injunction.
You should notify this office in writing within 15 working days from receipt of this letter. Your response should include each step taken or that will be taken to correct the violations and prevent recurrence. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your response should be sent to: U.S. Food & Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, NJ 07054, Attn: Sarah A. Della Fave, Compliance Officer. If you have any questions regarding any issue in this letter, you may contact Ms. Della Fave at 973.331.4910.
Sincerely,
/S/
Diana Amador-Toro
District Director
New Jersey District
cc: Mr. Joao Marcolino
Production Manager
Paramount Muffins, LLC
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