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CLOSEOUT LETTER

Shah Poran Distributors Inc May 11, 2016

Shah Poran Distributors Inc - Close Out Letter 5/11/16


Shah Poran Distributors Inc

  

Department of Health and Human Services' logoDepartment of Health and Human Services

 
 New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433
Office Hours: 8:00 AM-4:30 PM
General Telephone Line: 718-340-7000
Consumer Complaint Line: 1-866-446-9055
Import Entry Status Desk: 718-662-5692

May 11, 2016

Mr. Ahmad Abuallan, Managing Director
Shah Poran Distributors Inc
5609/11 56th Dr
Maspeth, NY 11378-1123, US

Reference: Inspection Date(s): 01/15/2016 - 02/24/2016 and 06/23/2015-06/25/2015

Location: Shah Poran Distributors Inc.
                5609/11 56th Dr.
                Maspeth, NY 11378-1123, US

Dear Mr. Ahmad Abuallan:

We are enclosing a copy of the establishment inspection reports (EIRs) for the inspections conducted at your premises on the referenced locate and date(s). When the Agency concludes that an inspection is "closed," under 21 C.F.R. 20.64(d)(3), it will release a copy of the EIR to the inspected establishment. This procedure is applicable to EIRs for inspections completed on or after April 1, 1997.

The Agency continually works to make its regulatory process and activities more transparent to the regulated industry. Releasing these EIRs to you is part of this effort. The copies being provided to you comprises the narrative portion of the report; it may reflect redactions made by the Agency in accordance with the Freedom of Information Act (FOIA) and 21 CFR Part 20. This, however, does not preclude you from requesting additional information under FOIA.

Additionally, we have completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK-2015-47 dated August 12, 2015. Based on our evaluation, it appears that you have addressed the violation contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

Although we are considering your inspections closed at this time, we have the following outstanding concerns relative to your most recent inspection dated 01/15/2016 - 02/24/2016:

Observation #1 stated:

You do not have or have not implemented written verification procedures and product specifications for ensuring that fish you import are processed in compliance with the Seafood HACCP regulation. Specifically, you do not have or have not implemented written verification procedures and product specifications for:

Frozen Hilsa Fish processed by Myint Myat Hein (Cold Store), 18 Myintzu St., Parami, Yeiktha, Yankin Township, Yangon Myanmar.
Frozen Keski processed by BD SEAFOOD LIMITED, CDA PLOT NO. 68-W(P), SAGORIKA ROAD, PHARTALI, CHITTAGONG, BANGLADESH.

We acknowledge that during this follow up inspection it appears you have been able to correct your Warning Letter violation with respect to lack of an affirmative step for your imported products, however, your firm has been reported (as noted above and on the FDA-483) to lack the product specifications and importer verification procedures also required by Seafood HACCP Regulations for the cited products. As part of your written Warning Letter response dated October 23, 2015 from your hired consulting firm Pecora Consulting LLC, you provided product specification and importer verification procedures for Frozen Hilsa Fish. Your firm should locate these documents and review them for accuracy or re-create them and then implement regular reference to these documents as part of your firm’s regular operations. Product specifications and importer verification procedures should also be developed for any additional seafood products you import, including the Frozen Keski product cited on the FDA-483 during your most recent inspection. Product specifications and importer verification procedures are critical to ensuring an appropriate affirmative step for your imported seafood products and compliance with the Seafood HACCP Regulation, 21 CFR 123.12.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

If there is any question about the released information or the contents of this letter, feel free to contact me at (518) 453-2314 x 1015 or alternatively write to: LCDR Catherine M. Beer, US FDA, One Winner's Circle, Suite 110, Albany NY 12205.

For more information on the U.S. FDA, please visit our website at www.fda.gov.


Sincerely,

/S/

LCDR Catherine M. Beer
Compliance Officer
New York District
 

 

Enclosure: Establishment Inspection Reports

Cc: Abu Allan, President
      Shah Poran Distributors Inc.
      5609/11 56th Dr.
      Maspeth, NY 11378-1123, US