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WARNING LETTER

Bhavani Fruits & Vegetables LLC MARCS-CMS 541761 — Mar 16, 2018

Bhavani Fruits & Vegetables LLC - 541761 - 03/16/2018


Recipient:
Recipient Name
Mr. Mukund N. Patel
Bhavani Fruits & Vegetables LLC

5620 56th Street

Maspeth, NY 11378-1132
United States

Issuing Office:
New York District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Human and Animal Food Operations East
Division 1 

 

WARNING LETTER
CMS # 541761 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
March 16, 2018
 
Mr. Mukund N. Patel, President/Co-Owner
Mrs. Chhaya Patel, Vice-President/Co-Owner
Bhavani Fruits and Vegetables LLC
5620 56th Street
Maspeth, NY 11378-1132
 
  
Dear Mr. and Mrs. Patel:
 
The U.S. Food and Drug Administration (FDA) inspected your warehouse, Bhavani Fruits & Vegetables LLC, at 5620 56th Street in Maspeth, NY 11378-1132 from October 11-October 30, 2017. That inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule [21 CFR Part 117] (CGMP & PC rule). At the conclusion of the inspection, FDA issued an FDA-483, Inspectional Observations, listing the deviations found at your firm. We have not received any correspondence from your firm in response to the FDA-483. 
 
Based on FDA’s findings during the inspection we determined that your food products are 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 were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You may find the Act through the links in FDA’s home page at www.fda.gov.
 
The CGMP & PC rule includes requirements for employee training (subpart A), updated CGMPs (subpart B), and recordkeeping (subpart F). In addition, subpart C (and associated subparts) require covered food facilities to 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 the facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act [21 USC 342 and 343(w)]. Exemptions (21 CFR 117.5) and modified requirements (subpart D) are applicable to certain operations. You may find further information on the CGMP & PC rule through links in FDA's home page at http://www.fda.gov.
 
We note the following significant deviations: 
 
1.      You did not exclude pests from your food plant to protect against contamination of food, as required by 21 CFR 117.35(c). Specifically, during the inspection of your facility, FDA investigators noted evidence of bird and rodent activity. For example, our investigator observed apparent rodent gnaw holes on bags of (b)(4) rice located on the southeast portion of the ambient storage area and flour located in the Northwest corner of the ambient storage. Our investigator also observed apparent rodent excreta pellets (REPs) too numerous to count both on and around as well as underneath the bags of rice. In addition, FDA investigators found rodent nesting material inside one of these bags. Physical sample #INV1025533 was collected during the breakdown of the pallet of (b)(4) rice and was analyzed by our laboratory. The analysis of this sample confirmed the material collected consisted of rodent excreta pellets, gnaw holes, and nesting material. The analytical results for this sample confirm the presence of rodent activity within your facility. 
 
Moreover, our investigators observed one live mouse and several dead mice stuck to glue pads in your ambient storage area and in your walk-in cooler. Apparent REP’s were observed in multiple areas throughout the warehouse, including next to boxes of leafy green vegetables and on the floor next to boxes of spices, as well as next to spilled rice, underneath the counter where your firm’s microwave is located, inside the employee bathroom, and around a hole in the wall where the sewer line can be accessed.
 
In addition, our investigators observed avian activity during the inspection. Specifically, on each day of the inspection our investigators observed four birds flying throughout the warehouse and landing on top of stored food products.  Further, on each day of the inspection, the loading bay door was observed to be kept open and birds were observed flying in and out of your warehouse. Along the Northern wall of the ambient storage area, apparent avian droppings were observed on exterior cardboard packaging of (b)(4) rice and on all upper portions of pallet stacking frames, roof rafters and the exterior packaging of non-food items. The rice, pallet stacking frames, roof rafters, and non-food items were adjacent to a door located in the Northeast corner of the building and the loading bay door located along the Eastern wall of the building.
 
2.    You did not maintain your plant in repair adequate to keep food from becoming adulterated, as required by 21 CFR 117.35(a). Specifically, our investigators observed an approximately 1 inch gap under your firm’s front rolling door while in the closed position and a hole of approximately 4 inches in diameter on the south facing wall of your firm’s ambient storage area. Additionally, the strip curtains in your firm’s rolling door were observed to be ripped, with some panels missing, allowing four birds to fly in and out of the facility. Finally, the strip curtains in your firm’s walk-in cooler were observed to be ripped, with some panels missing, which could allow birds and flying pests to enter the cooler area. The birds could land on and contaminate the fresh vegetables which may not be cooked by the consumer.
 
We acknowledge that prior to the close-out of the inspection your firm repaired the front rolling door so that it could fully close and repaired the holes observed by the investigators during the inspection. However, you have not repaired the strip curtains, or provided information regarding how the corrections you have taken will be sustained and/or implemented to prevent recurrence.
 
3.    You did not store food under conditions that protect against deterioration and contamination, as required by 21 CFR 117.93. Specifically, our investigators observed several boxes of frozen peas & carrots and roti, stored on the floor in your firm’s walk-in freezer, wet with condensate from a broken fan and covered with an accumulation of ice (approximately 6 inches in height).  Furthermore, the boxes were ripped and had already collapsed due to the ice condensate that formed on top. 
 
Additionally, our investigators observed your firm storing recyclable waste in a dumpster inside your walk-in cooler where fresh produce is stored. The dumpster is left outside overnight for pick-up and is an attractant and potential breeding place and harborage for pests. When the dumpster is rolled inside the walk-in cooler, it could expose the fresh produce within the cooler to pests from outside. This dumpster was observed open and overflowing with cardboard and other materials. Additionally, your employees were observed using a large cardboard bin with no lid for the storage of trash. This bin was stored within your walk-in cooler. Food scraps and leftovers were observed inside this bin for several days. The open bin is an attractant and potential breeding place and harborage for pests, including rodents, that are looking for food. 
 
4.    Your plant did not have adequate sanitary facilities and accommodations, as required by 21 CFR 117.37. Specifically, our investigators observed that your employee bathroom lacked a sanitary drying device, hand washing soap and toilet paper on three different days.  
 
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 photographs or 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.
 
Please send your reply to the Food and Drug Administration, Attention: W. Martin Rennells, Compliance Officer, One Winners Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contact W. Martin Rennells at 518-453-2314 x1038 or william.rennells@fda.hhs.gov.
 
Sincerely,
/S/ 
Ronald Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1

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