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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Circulatory Technology, Inc. - Close Out Letter 2/17/12

  

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

Public Health Service
Food and Drug Administration
 New York District
158-15 Liberty Ave.
Jamaica, NY 11433
 

February 17, 2012
 

Mr. Yehuda Tamari, President
Circulatory Technology, Inc.
21 Singworth Street
Oyster Bay, NY 11771

Dear Mr. Tamari:

We are enclosing a copy of the establishment inspection reports (EIR) for the inspections conducted at your premises of 21 Singworth Street, Oyster Bay, NY 11771 on:

• March 9, 2010 through March 15, 2010 by Ronald Ifraimov, Investigator of the U.S. Food and Drug Administration (FDA) as well as;
• April 21, 2011 through April 25, 2011 by Kwong Lee, Investigator of 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 new procedure is applicable to EIRs for inspections completed on or after April 1, 1997. For those inspections completed prior to the above date, a copy of the EIR may still be made available through the Freedom of information Act (FOIA).

The Agency is working to make its regulatory process and activities more transparent to the regulated industry. Releasing this EIR to you is part of this effort. The copy being provided to you comprises the narrative portion of the report; it reflects redactions made by the Agency in accordance with the FOIA and 21 C.F.R. Part 20. This, however, does not preclude you from requesting and, possibly, obtaining any additional information under FOIA.

If there is any question about the released information, feel free to contact Frank Verni, Compliance Officer at (718) 662-5702 or write to: US Food & Drug Administration; Attn: Frank Verni, Compliance Officer, New York District, 158-15 Liberty Ave, Room 4050, Jamaica, NY 11433.

Sincerely,

/s/

LCDR Frank Verni, USPHS
Compliance Officer
FDA- New York District