- Stat Medical Devices, Inc.
- Issuing Office:
555 Winderley Place #200
Maitland, FL 32751
Telephone: (407) 475-4700
VIA ELECTRONIC MAIL
March 28, 2018
Mr. Steven Schraga, President
Stat Medical Devices, Inc.
2056 NE 153rd Street
Miami, FL 33162 U.S.A.
RE: Warning Letter Close-Out Letter – FEI 1000525253
CMS Case ID: 473754, CMS WA ID: 144791
Dear Mr. Schraga:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter FLA-15-29, dated July 23, 2015. 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.
Acting Program Division Director
Division of Medical Devices and
Radiological Health Operations II Central