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CLOSEOUT LETTER

Adriatic Seafood Inc May 23, 2017

Adriatic Seafood Inc - Close Out Letter 5/23/17


Adriatic Seafood Inc

 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Human and Animal Food Operations East Division 1 

May 23, 2017

VIA US POSTAL SERVICE

Mr. Safet Kovacevic, President/Part-Owner
Adriatic Seafood Inc.
129 Willow Ave
Staten Island, NY 10305-1814

Dear Mr. Kovacevic:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2016-34 issued June 16, 2016. Based on our evaluation, we conclude that you have satisfactorily addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

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.

We are enclosing a copy of the establishment inspection reports (EIRs) for the inspections conducted at your premises located at 129 Willow Ave, Staten Island, NY 10305 on April 22, 2016 through May 12, 2016 and May 2 through May 4, 2017 by the U.S. Food and Drug Administration (FDA). 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 inspection completed on or after April 1, 1997.

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

If there is any question about the released information, feel free to contact Scott R. Izyk, Compliance Officer at 518-453-2314 ext. 1012 or write to: U.S. Food and Drug Administration, Office of Human and Animal Food Operations East, Division 1, 158-15 Liberty Ave, Jamaica, NY 11433.
 

Sincerely,
/S/

Scott R. Izyk
Compliance Officer
Office of Human and Animal Food Operations
East Division 1