Regulatory Open Forum

​​​Hi;

Is it possible to have FDA Inspection of the brand-new Facility before product approval?

------------------------------
Pravin Rothe
------------------------------

​Hi Pravin.

I would say "yes" it is possible.  Once you register the facility with the FDA the agency can come in at any point to inspect.  Just think about the process of "pre-approval inspections" for new products.  If the new product is the first item to be manufactured at the new facility then there certainly would be an FDA inspection before you actually have a product "approved".

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States
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Original Message:
Sent: 14-Aug-2017 16:11
From: Pravin Rothe
Subject: cGMP Inspection of the Facility

​​​Hi;

Is it possible to have FDA Inspection of the brand-new Facility before product approval?

------------------------------
Pravin Rothe
------------------------------

Thank you Victor.
I mean before product filing? We have received the FEI number from the FDA but would like to have facility inspection by FDA so that we can proceed for contract manufacturing.


------------------------------
Pravin Rothe
------------------------------

Original Message:
Sent: 15-Aug-2017 08:10
From: Victor Mencarelli
Subject: cGMP Inspection of the Facility

​Hi Pravin.

I would say "yes" it is possible.  Once you register the facility with the FDA the agency can come in at any point to inspect.  Just think about the process of "pre-approval inspections" for new products.  If the new product is the first item to be manufactured at the new facility then there certainly would be an FDA inspection before you actually have a product "approved".

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States

Original Message:
Sent: 14-Aug-2017 16:11
From: Pravin Rothe
Subject: cGMP Inspection of the Facility

​​​Hi;

Is it possible to have FDA Inspection of the brand-new Facility before product approval?

------------------------------
Pravin Rothe
------------------------------

It is advisable to do the cGMP inspection by the agency before starting any contract manufacturing or any product filing.

Company gets inputs from the agency for any update in the facility, systems, SOPs, etc. that you meet the minimum standard and agency will also appreciate your preventive measures to stay in compliance before you start actual manufacturing.

------------------------------
Gaurang Bhavsar, MS, RAC
Scientist-II, R&D and RA
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065
USA
------------------------------

Original Message:
Sent: 16-Aug-2017 11:22
From: Pravin Rothe
Subject: cGMP Inspection of the Facility

Thank you Victor.
I mean before product filing? We have received the FEI number from the FDA but would like to have facility inspection by FDA so that we can proceed for contract manufacturing.


------------------------------
Pravin Rothe

Original Message:
Sent: 15-Aug-2017 08:10
From: Victor Mencarelli
Subject: cGMP Inspection of the Facility

​Hi Pravin.

I would say "yes" it is possible.  Once you register the facility with the FDA the agency can come in at any point to inspect.  Just think about the process of "pre-approval inspections" for new products.  If the new product is the first item to be manufactured at the new facility then there certainly would be an FDA inspection before you actually have a product "approved".

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States

Original Message:
Sent: 14-Aug-2017 16:11
From: Pravin Rothe
Subject: cGMP Inspection of the Facility

​​​Hi;

Is it possible to have FDA Inspection of the brand-new Facility before product approval?

------------------------------
Pravin Rothe
------------------------------

Dear Pravin,

It is not possible to request FDA inspect a facility. Upon filing your marketing application, FDA will make the decision to inspect (or not) the manufacturing facility producing product that is the subject of the marketing application.

You may obtain an inspection from another regulatory authority through PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme).

Another way to obtain a FDA-like inspection is to hire a former FDA inspector as a consultant. This consultant can preform a mock-FDA inspection.

Sincerely yours, Suzanne

------------------------------
Suzanne Sensabaugh
President and Principal Consultant
Hartmannwillner LLC
Washington DC
United States
------------------------------

Original Message:
Sent: 16-Aug-2017 11:22
From: Pravin Rothe
Subject: cGMP Inspection of the Facility

Thank you Victor.
I mean before product filing? We have received the FEI number from the FDA but would like to have facility inspection by FDA so that we can proceed for contract manufacturing.


------------------------------
Pravin Rothe

Original Message:
Sent: 15-Aug-2017 08:10
From: Victor Mencarelli
Subject: cGMP Inspection of the Facility

​Hi Pravin.

I would say "yes" it is possible.  Once you register the facility with the FDA the agency can come in at any point to inspect.  Just think about the process of "pre-approval inspections" for new products.  If the new product is the first item to be manufactured at the new facility then there certainly would be an FDA inspection before you actually have a product "approved".

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States

Original Message:
Sent: 14-Aug-2017 16:11
From: Pravin Rothe
Subject: cGMP Inspection of the Facility

​​​Hi;

Is it possible to have FDA Inspection of the brand-new Facility before product approval?

------------------------------
Pravin Rothe
------------------------------