CLOSEOUT LETTER
86 Harriet Ave Corporation DBA General Devices
- Product:
- Medical Devices
- Recipient:
- 86 Harriet Ave Corporation DBA General Devices
United States
- Issuing Office:
United States
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Office of Medical Device and Radiological |
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August 2, 2017
Curt M. Bashford
President and CEO
86 Harriet Ave. Corporation OBA General Devices
1000 River Street
Ridgefield, NJ 07657-1610
Dear Mr. Bashford:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter (16-NWJ-07) dated June 01, 2016. 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/
Gina M. Brackett
Acting Director Compliance Branch
Office of Medical Device and Radiological
Health Operations (OMDRHO) Division 1- East