Inspections, Compliance, Enforcement, and Criminal Investigations
Indian Foods & Spices, LLC 8/7/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Telephone (973) 331-4908
August 7, 2012
VIA UPS OVERNIGHT
Mr. Vivek R. Pandit
Partner and Co-Owner
Indian Food & Spices, LLC
970 B New Brunswick Ave.
Rahway, NJ 07065
Dear Mr. Pandit
File No.: 12-NWJ-19
The Food and Drug Administration (FDA) conducted an inspection of your food warehouse, located at 970 B New Brunswick Ave., Rahway, NJ 07065, from April 6, 2012 through April 17, 2012. During the inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). The inspection revealed that food stored at 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 the food products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth.
In addition, a sample of Basmati Rice, Sample Number 726279, was collected during the inspection and was analyzed by FDA's Pacific Regional Laboratory Southwest Laboratory analysis confirmed the presence of rat/mouse hair and hair fragments, feather barbs, caterpillar fragments, Silvanid beetles (larvae, pupae and cast skin), Tenebrionid beetle larva, bird excreta, beetle fragments, and urine contamination. Their presence causes the product to be adulterated within the meaning of Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(3)] in that it consists in whole or in part of a filthy, putrid, or decomposed substance, or is otherwise unfit for food. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov.
We received your written response dated April 26, 2012. We acknowledge that your firm destroyed the aforementioned lot of Basmati Rice. We also acknowledge that you have obtained proposals from a pest control company specializing in bird control However. your response is not adequate because you did not provide evidence that you have started the recommended services or have otherwise eliminated the birds from your facility.
The investigators observed the following significant violations during the inspection.
1. You failed to take effective measures to exclude pests from. your facility and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, our investigators observed:
a. Live birds within your facility including on and above stored, packaged food and storage racks used to hold bags and boxes of finished product
b. Dead rodents within your facility including on and between packaged foods stored on a pallet and on the floor between pallets of rice.
c. Bird excreta and bird excreta stains were found within your warehouse. Specifically, on April 9, 2012,
i. Bird excreta were on the outside surface of (b)(4) Garlic & Chili exterior boxes located on a pallet.
ii. Bird excreta were on the outer packaging and rice located directly beneath gnawed packaging of one 40 lb bag India Gate Basmati Rice.
iii. Bird excreta were on the warehouse floor and storage racks.
d. Rodent excreta pellets (REPs) were found within your warehouse on April 9, 2012, including:
i. One REP was on rice directly beneath gnawed packaging of one 40 lb India Gate Basmati Rice bag.
ii. Eleven REPs were on rice directly beneath gnawed packaging of one 40 lb India Gate Basmati Rice bag.
iii. Fifteen REPs were on the warehouse floor behind boxes containing packaged food.
iv. Three REPs were on top of boxes containing (b)(4) Garlic & Chili.
e. Rodent nesting was found within your warehouse on April 11, 2012 between the burlap bags of Mehak brand Sana Masoori Rice and the plastic wrap surrounding the pallet. On April 12, 2012, rodent nesting was also found between burlap bags of (b)(4) brand Masoori Rice.
f. Rodent gnawing was found within your warehouse on April 9, 2012, including:
i. Four exterior cardboard packaging of (b)(4) Garlic & Chili.
ii. (b)(4) Biscuits contained gnaw markings on the exterior packaging, primary exterior packaging, and one biscuit cookie.
iii. Parle Hide & Seek: Finest Chocolate Chip Cookies contained gnaw markings on the secondary packaging and one cookie.
iv. Two 40 lb bags of India Gate Basmati Rice.
g. Insect activity was found within your warehouse on April 9, 2012, including:
i. One Parasitic wasp was located on top of boxes containing (b)(4) Garlic & Chili product
ii. Six Silvanid beetles (Oryzaephilus surinamensis Linnaeus), one Silvanid beetle head/thorax. one dermestid beetle jarval cast skin, and one caterpillar head were located on the warehouse floor behind boxes containing packaged food.
iii. Two Silvanid beetles, six Silvanid beetle larvae, one caterpillar, one caterpillar head, and one parasitic wasp were located on rice directly beneath gnawed packaging of a 40 lb India Gate Basmati Rice bag.
h. Urine staining was found within your warehouse on April 9, 2012 including,
i. On rice directly beneath gnawed packaging of one 40 lb bag of India Gate Basmati Rice.
ii. On one 40 lb bag of India Gate Basmati Rice.
iii. On six boxes of (b)(4) Garlic & Chili exterior cardboard packaging.
Your response states that you have voluntarily destroyed the aforementioned products and you have obtained proposals from a pest control company specializing in bird control. However, your response is not adequate because you did not provide evidence that you have started the recommended services or have otherwise eliminated the birds from your facility.
2. You failed to maintain buildings, fixtures and other physical facilities in a sanitary condition to prevent food from being contaminated, as required by 21 CFR 110.35(a). Specifically, our investigators observed spilled rice on the pallets and floor of your warehouses in close proximity to stored food products, whereby such products may become contaminated.
3. You failed to take proper precautions to protect food from contamination with filth because of deficiencies in plant size and design as required by 21 CFR 110.20(b)(2). These conditions limit access for cleaning and inspection for pests.
a. Pallets of food products were stored directly against the wall.
b. Pallets of food products were stored in the aisles against other pallets of food products.
c. The receiving and loading steel roll-up doors were observed open to the exterior while the doors were not in active use.
d. A corner gap in the wall between the receiving and loading area was observed. The bay doors of a neighboring facility were observed through this gap.
e. The doorway, in the receiving and loading area, which leads directly outside was observed open to the exterior while the door was not in active use.
We acknowledge the statement in your response that the gap in the receiving and loading area has been "temporarily" sealed. This action does not fully address the violation because the seal is temporary in nature and you have not given a timeframe for complete correction. Your response also acknowledges that there are holes and gaps in the roof, but you did not provide a timeframe as to when they will be sealed. We acknowledge that in your response you are negotiating more space and have moved the racks away from the wall; however, you did not address a timeframe for complete correction.
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. A re-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 the re-inspection and assessing and collecting the re-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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter. please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be addressed to U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054, Attn: Kerry Kurdilla, Compliance Officer.
New Jersey District