FDA Establishment Registration - Does registration require compliance to the QSR?

As a contract manufacturer, one of our clients has requested that we be FDA registered. Does registration require compliance to the QSR?

Quality Queen said:

As a contract manufacturer, one of our clients has requested that we be FDA registered. Does registration require compliance to the QSR?

Click to expand...

In a word, yes. If you are registering, you manufacture a medical device. If you are manufacturing a medical device for import into the US, you must meet the requirements of the QSR.

I've finally received an answer from a person inside the FDA regarding this matter and I wanted to share it.

An establishment registration for a contract manufacturer does NOT require an FDA inspection or require evidence of compliance with QSR. However, the contract manufacturer might be subject to auditing by the customer to ensure the quality of the product supplied.

Contract manufacturers are not required to include a products list, or get approval on the products (that is the responsibility of their customer) and it is only when you apply for a 510(k) that you would be subject to an FDA inspection.

I suspected that this was the case since there is no fee for the establishment registration and the form was so simple.

Quality Queen said:

Contract manufacturers are not required to include a products list, or get approval on the products (that is the responsibility of their customer) and it is only when you apply for a 510(k) that you would be subject to an FDA inspection.

I suspected that this was the case since there is no fee for the establishment registration and the form was so simple.

Click to expand...

That is way off base. We are a service provider (testing, packaging, and sterilization) to medical device companies, we do not make a product and we are audited/inspected by the FDA on a regular basis. Not sure who you spoke with but you may want to check into that.

Also, if you are providing Medical Device customers with product you better believe they will expect you to be in compliance with the QSR. Just some food for thought.

Quality Queen:

I tend to agree with ISO Guy. Be careful. If you ask two government people a question you can get three different answers. See the following from the CDRH web site:

In one section it states that contract manufacturers are exempt, but then states:


Contract Manufacturers

A person(s) that manufactures a finished device under the terms of a contract with another manufacturer is a contract manufacturer. The agreement between the manufacturers should be documented in a written contract. Contract manufacturers of finished devices shall comply with applicable requirements of the quality system and shall register their establishment with FDA. Depending on the circumstances, both the contractor and manufacturer may be held jointly responsible by FDA for the activities performed.


http://www.fda.gov/cdrh/qsr/01qsreg.html#GMP_applications_and_exemptions

Also, if you have an FDA registration number you are fair game for them to inspect. Now depending on what you are doing will dicate how often they will be knocking on your door.

Just to let you know we have thre seperate registration numbers 1 building has seen the FDA shop up 3 times within a 1 1/2 year period, the other two have never been visited.

ISO GUY said:

Also, if you have an FDA registration number you are fair game for them to inspect. Now depending on what you are doing will dicate how often they will be knocking on your door.

Just to let you know we have thre seperate registration numbers 1 building has seen the FDA shop up 3 times within a 1 1/2 year period, the other two have never been visited.

Click to expand...

I can echo this in a small way. When I was with a high tech contract manufacturer (machining), we held an FDA certificate for ten years. The FDA never showed up on our doorstep in ten years even though the local office was only fifteen minutes away. We only sold to other FDA-registered organizations who designed the products we made for them (bone screws, dental instruments, housings for electronics.) We also made stuff for aerospace. All our aerospace component contracts from FAA-certified manufacturers stipulated the FAA could inspect us at any time although we were not certified by the FAA. We never had a visit from the FAA, either, and they were also only 15 minutes away.

However, now that I am with an FAA-certified Parts Manufacturer, we see the FAA on a regular basis (always announced in advance.) The FAA has not visited any of our non-FAA-certified suppliers, although all our contracts carry the same stipulation (mandated by FAA) that FAA may inspect them at any time.

Thanks for your help everyone! It looks like we're going to try to implement some changes to our quality system to encorporate the QSR. Thankfully, we're already registered to ISO13485 so we've got a good start on it. No doubt I'll be searching posts for guidance with it since my first attempt with FDA!

One more question: If the FDA decides to inspect us, what kind of costs should we expect? (i.e. do we have to pay for the inspection, travel costs for the inspector, etc. as we do with ISO certification?)

Quality Queen said:

Thanks for your help everyone! It looks like we're going to try to implement some changes to our quality system to encorporate the QSR. Thankfully, we're already registered to ISO13485 so we've got a good start on it. No doubt I'll be searching posts for guidance with it since my first attempt with FDA!

One more question: If the FDA decides to inspect us, what kind of costs should we expect? (i.e. do we have to pay for the inspection, travel costs for the inspector, etc. as we do with ISO certification?)

Click to expand...

Quality Queen-

If you are already ISO 13845 Certified you should have no problems.

If the FDA does inspect you there would be no cost to your orginization. In fact you can't even buy them lunch, heck ours wouldn't even accept a glass of water. The cost is absorbed by the Government.