CLOSEOUT LETTER
Pelvic Therapies, Inc MARCS-CMS 518409 —
- Recipient:
- Pelvic Therapies, Inc
United States
- Issuing Office:
United States
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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