| Public Health Service Food and Drug Administration |
| Waterview Corporate Center 10 Waterview Blvd., 3rd Floor. Parsippany, NJ 07054 Telephone (973) 331-4904 |
Department of Health and Human ServicesNovember 1, 2010
WARNING LETTER
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
Mr. Sajjad Ahmed
President & Owner
Kashmir Crown Baking LLC
710 West Linden Avenue
Linden, New Jersey 07036
11-NWJ-02
Dear Mr. Ahmed:
This letter is regarding our July 23, 2010 through July 29, 2010 inspection of your bakery manufacturing facility, located at 710 West Linden Avenue, Linden, New Jersey. During the inspection our investigators identified violations of the Current Good Manufacturing Practice Regulation (cGMPs) Title 21, Code of Federal Regulations, Part 110. These violations caused your food products to be adulterated within the meaning of Section 402(a)(4) of the 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 become contaminated with filth, or whereby they may have been rendered injurious to health. The observations were presented to you on an FDA-483 at the conclusion of our inspection on July 29, 2010.
The specific CGMP violations observed during the inspection include, but are not limited, to the following:
1. Failure to store raw material food products in a manner to protect against contamination. [21 CFR 110.80(a)(1)].
• Your walk-in refrigerator located near the raw material storage and finished product staging area contained two uncovered buckets of cream intended for use as filling for pastry products. The buckets were stored directly on the ground with one bucket of cream containing food debris resembling chocolate sauce, chocolate chips, and unidentifiable yellow debris.
2. Failure to clean and sanitize food-contact surfaces and utensils to protect against contamination. [21 CFR 110.35(d)].
• The blades of the slicing machine which is used to slice Cake Rusk products are not cleaned and sanitized between production runs of different products.
3. Failure to have adequate hand-washing facilities. [21 CFR 110.37(e)].
• The hot water valve to the hand-wash sink in the Mixing Area was shut off so that only cold water was available. The power to the hand-drying unit was turned off and there were no other hand drying devices (such as paper towel) available.
4. Employees did not wash hands thoroughly in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated. [21 CFR 110.10(b)(3)].
• Your employees were observed touching non-food-contact surfaces of equipment, their faces, and their arms immediately before handling food products, without washing their hands.
5. Failure to confine eating to areas other than where food is exposed. [21 CFR 110.10(b)(8)].
• Specifically, an employee was observed eating what appeared to be a roll in the mixing room. Your president stated that employees do eat while they work.
6. Failure to store personal belongings in areas other than where food is exposed or where equipment or utensils are washed. [21 CFR 110.10(b)(7)].
• During the inspection, the investigator observed an employee’s soda bottle filled with water in the walk-in refrigerator sitting directly on top of shelled peanuts stored in cloth bags.
7. Failure to implement effective measures to exclude pests from your processing areas and protect against the contamination of food. [21 CFR 110.35(c)]. Your facility lacks adequate screening or other protection against pests. [21 CFR 110.20(b)(7)].
• The screen doors leading into food production areas contain gaps allowing entry for pests. Numerous flies were observed in the Mixing Area and one fly was observed lading on dough held in a large mixing unit.
This letter is not intended to be an all-inclusive list of the violations at your bakery. It is your responsibility to ensure that you operate your bakery in compliance with the Act, the Current Good Manufacturing Practice Regulations (21 CFR 110), and all other FDA implementing regulations and requirements of federal law. We recommend that you conduct a comprehensive evaluation of your facility to determine CGMP compliance. It is also your responsibility to investigate and determine the causes of the violations identified above and to prevent their recurrence.
You should take prompt action to correct the violations cited in this letter. We may take further action if you do not promptly correct these violations. For instance, we may seize your product(s) and/or enjoin your firm from operating.
In addition to the violations discussed above, we have the following comments:
• We note that a cigarette butt was observed on the floor of the mixing room. You have a responsibility to ensure that your no-smoking policy is followed in accordance with 21 CFR 110.10(b)(8).
• Your president stated that you do not maintain records of the lot numbers of food products you ship with each customer order. You have a responsibility to establish and maintain records regarding the food you release in accordance with 21 CFR 1.345. In particular, you must establish and maintain records of the lot or code number or other identifier of the food you release as required by 21 CFR 1.345(a)(4).
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations and to prevent their recurrence. You should include in your response documentation such as copies of cleaning logs, training logs, photographs of corrective measures, 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 the delay and state when you will correct any remaining violations.
Your response should be sent to the following address: U.S. Food & Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey 07054, Attn: Andrew Ciaccia, Compliance Officer.
Sincerely,
/S/
Diana Amador-Toro
District Director
New Jersey District Office
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