Bridge Regulatory Affairs, LLC: octreotide hydrochloride extended- release

, listed in this application, FDA conveyed deficiencies to the representative of the facility.

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA Form 483 prior to your complete response.

If is still your preferred proprietary name, please resubmit a request for proprietary name review ri when you respond to all of the application deficiencies that have been identified in this letter.

FDA conveyed deficiencies to the representative of the facility.

Satisfactory responses from the facility are needed before this application can be approved.

The facility's satisfactory responses are dependent on FDA's determination that the facility has come into compliance with CGMP and may require re-inspection of the facility.

Following resolution of the CGMP inspection, FDA may need to conduct a pre-approval inspection (PAI) of the facility.

Satisfactory outcomes of both the PAI and the CGMP inspections will be needed prior to an approval of the application.

We note that you submitted a response on , and request that you include this in your application resubmission.