Regulatory Open Forum

Please assist to define the following terms and questions and describe what they mean or signify?

1. FDA-registered facility:
2. FDA-inspected facility:
3, FDA-approved facility
4. Other than a manufacturer which requires it to be a FDA-registered facility, what other entities (firms) are required to be FDA-registered facilities..e.g. primary repacker, secodary repacker, any other types of entities?
5. If a facility is designated FDA-registered, what does mean for the facility, i.e. has FDA inspected that facility and approved its operations as to what it intends to do as to its operation? Can they keep that designation and not do anything at all? Do they need to start manufacturing drugs (subject to meeting cGMP standards per FDA approval)?

Thank you.


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Dr. Vaiyapuri Subramaniam PharmD
Assoc Chief Consultant &n Dir ADE Reporting Progs
Silver Spring MD
United States
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1. FDA-registered facility:

Registration or in the case of Medical Devices, Registration and listing, is required under the FD&C act and it is a way for a facility to tell FDA their physical location. This is so because FDA needs to know where they need to go if they inspect or need to respond to an emergency. Registration does not mean you can market your product (except in the case of a Class I Premarket notification/ approval exempt products) you still have to go through the normal pre-market approval process to market your product.

2. FDA-inspected facility:
Anyone who has had an FDA inspection can claim that they are FDA inspected (even if the passed or Failed the inspection). In my opinion this is a marketing term and does not have any regulatory significance.

3, FDA-approved facility:

No such thing. FDA does not approve or disapprove a facility which is different  from ISO regulations. FDA approves products and not facilities. This is another marketing term miss used though I suspect if the FDA compliance people had more manpower they may crack down on these claims.

4. Other than a manufacturer which requires it to be a FDA-registered facility, what other entities (firms) are required to be FDA-registered facilities..e.g. primary repacker, secodary repacker, any other types of entities?

FDASIA the new law signed in 2012 has changed the requirements for instance on the device side Contract manufacturers, contract sterilizers who did not have to register before the law are now required to Register and list (starting October 2012). See entire list here ).

Feel free to contact me if you have additional questions.

Shree Koushik
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Srinagesh Koushik  PhD RAC
Damascus MD
United States
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Original Message:
Sent: 10-25-2012 14:37
From: Vaiyapuri Subramaniam
Subject: Please assist with defining the following terms

Please assist to define the following terms and questions and describe what they mean or signify?

1. FDA-registered facility:
2. FDA-inspected facility:
3, FDA-approved facility
4. Other than a manufacturer which requires it to be a FDA-registered facility, what other entities (firms) are required to be FDA-registered facilities..e.g. primary repacker, secodary repacker, any other types of entities?
5. If a facility is designated FDA-registered, what does mean for the facility, i.e. has FDA inspected that facility and approved its operations as to what it intends to do as to its operation? Can they keep that designation and not do anything at all? Do they need to start manufacturing drugs (subject to meeting cGMP standards per FDA approval)?

Thank you.


-------------------------------------------
Dr. Vaiyapuri Subramaniam PharmD
Assoc Chief Consultant &n Dir ADE Reporting Progs
Silver Spring MD
United States
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The place to start is the FDA web site.  Simply search for "registration" and review FDA guidance documents.  There is a specific section on "who needs to register."  It also covers who does not need to register, e.g., most distributors. 

Registration does not mean FDA has inspected the facility.   Facilities may be approved to make certain products, but beware of the term "FDA approved facility"  It does not necessarily mean the facility is approved to make anything other than specifically approved, cleared or licensed products.
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Glen Freiberg
President, RCQ Consulting
Rancho Santa Fe CA
United States
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Original Message:
Sent: 10-25-2012 14:37
From: Vaiyapuri Subramaniam
Subject: Please assist with defining the following terms

Please assist to define the following terms and questions and describe what they mean or signify?

1. FDA-registered facility:
2. FDA-inspected facility:
3, FDA-approved facility
4. Other than a manufacturer which requires it to be a FDA-registered facility, what other entities (firms) are required to be FDA-registered facilities..e.g. primary repacker, secodary repacker, any other types of entities?
5. If a facility is designated FDA-registered, what does mean for the facility, i.e. has FDA inspected that facility and approved its operations as to what it intends to do as to its operation? Can they keep that designation and not do anything at all? Do they need to start manufacturing drugs (subject to meeting cGMP standards per FDA approval)?

Thank you.


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Dr. Vaiyapuri Subramaniam PharmD
Assoc Chief Consultant &n Dir ADE Reporting Progs
Silver Spring MD
United States
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