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  5. Pelvic Therapies, Inc - Close Out Letter 8/7/18
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CLOSEOUT LETTER

Pelvic Therapies, Inc


Recipient:
Pelvic Therapies, Inc


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
Los Angeles District
19701 Fairchild Road
Los Angeles, CA 92612

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

August 7, 2018

Ms. Elizabeth Janapol, Owner
Pelvic Therapies, Inc.
390 Oak Ave., Suite G
Carlsbad, CA 92008

Dear Ms. Janapol:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL #518409-18), dated 10/17/2017. Based on our evaluation, it appears that you have addressed the violation(s) contained in this 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.

Sincerely,
/S/

Kelly D. Sheppard
Compliance Branch Director
Division 3/West
Office of Medical Device and Radiological Health Operations