CLOSEOUT LETTER
Frontida BioPharm Inc
- Recipient:
- Frontida BioPharm Inc
United States
- Issuing Office:
United States
| |
Philadelphia District 900 U.S. Custom House 2nd and Chestnut Street Philadelphia, PA 19106 Telephone: (215) 597-4390 |
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
April 28, 2017
Ronald H. Connolly, Chief Operation Officer
Frontida BioPharm Inc.
1100 Orthodox Street
Philadelphia, PA 19124
Dear Mr. Connollly:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 16-PHI-10, dated August 15, 2016. Based on our evaluation, it appears that you have addressed the violation(s) contained in the 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 you firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and it 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/
Yvette Johnson
Compliance Officer
Philadelphia District Office