Contract Manufacturer must adhere to 21 CFR 820 - Can FDA require us to do this?

M

MIREGMGR

#21
The FDA recently issued a Warning Letter to a contract manufacturer that is not the marketer of the product. I think it's of interest for this thread.

My perception of the warning letter is that it was issued because a significant part of the shortfall was in regard to sterile barrier packaging followed by sterilization. These of course are activities that are highly regulated.

The FDA clearly denoted the contract manufacturer as such, but then described them as a finished product manufacturer. Under the existing guidances, it's not apparent that a company can be both at once. If the "finished product" characterization is because the contract manufacturer is conducting sterile barrier packaging and sterilization, one wonders what the implications are for contract service providers that specifically provide these two services, but do nothing else. Are they the device maker, even if they had nothing to do with making the device itself?

I think this instance makes clear that whatever the FDA provides as general guidance regarding outsourcing and contract/component manufacturing and services, they are willing to override that guidance when they believe its requirements would not be adequate to control an outside vendor's procedural shortcomings that negatively affect medical device safety and effectiveness.
 
Last edited by a moderator:
Elsmar Forum Sponsor
G

Gerry Quinn

#22
FYI - The company mentioned in the warning letter is a contract manufacturer that is registered with the FDA and as such would be subject to FDA inspections.
 
M

MIREGMGR

#23
Companies that declare at establishment registration that they are only contract manufacturers sometimes don't expect to be inspected. A Level 1 QSIT inspection covers operational elements that a contract manufacturer is not required to have in place, if all that they do is manufacturing to their customer's specification...no specification creation, no distribution and marketing, no post market surveillance and receipt of customer feedback. I know of contract manufacturers that are registered establishments, but for whom those conditions apply.

But, companies that conduct sterile-barrier packaging and sterilization are always subject to inspection, as I understand it.

In this instance, it appears to me that the FDA decided to bend the definition of "makes a finished device" in order to deal with this instance of a contract manufacturer that does sterilization. The point I was trying to make is that the guidelines are bendable, as the FDA sees fit to meet their strategic goals.
 

Doug Tropf

Quite Involved in Discussions
#24
The FDA's Compliance Policy Guide (Section 100.550) states that contract sterilizers, as drug or device processors, are subject to the *inspectional* requirements of the Act.
 
J

jscholen

#25
The way I read the " This regulation does not apply to manufacturers of components...", is that it applies to the previous sentence regarding design controls.

The real application here is the code( 820.1(a)(1) " ...If a manufacturer engages in only some operation subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged."

My 2 cents...This is why you got dinged.
 
G

Gerry Quinn

#26
This is part of the preamble to 21CFR820. It was the original intention of the FDA to include 'component manufacturers' in the original version of the QSR. The last sentence is relative here.
 

Attachments

J

JayJay

#28
Re: Can FDA require us to do this?

Here is a helpful chart from FDA's IOM (Investigations Operations Manual- Ch 5 Exhibit 13) that differenciates the types of medical device operations and FDA obligations. http://www.fda.gov/ora/inspect_ref/iom/exhibits/5-13.pdf
I'm really glad you posted this because someone had emailed me that exact spreadsheet and said that it was from the FDA, but couldn't find the link. This very spreadsheet is actually what prompted me to start this thread.

Our contract manufacturer does not manufacture finished devices and doesn't distribute them 3(b), which indicates that they would not need to comply with the GMP according to 3(B) of this spreadsheet. Our District Office, however, is still saying that they do need to comply with the portions that apply to them (Prod / Process Controls). When I read the regulation scope 820.1 (1) it says that component manufacturers are "encouraged to use appropriate provisions of this regulation as guidance".

I am still trying to work with our District Office to ensure that they understand what our relationship is with our manufacturer, as I'm beginning to think it's just been miscommunicated. If not, I am fully prepared to fight with them on this because I can justify our position based on 820.1 (1) and 807.20 (c)(1).

I would certainly hate to think that the FDA is working against their own written regulations and procedures! Can I give them a 483 for that? HA!
 
M

MIREGMGR

#29
Re: Can FDA require us to do this?

Our contract manufacturer does not manufacture finished devices and doesn't distribute them 3(b), which indicates that they would not need to comply with the GMP according to 3(B) of this spreadsheet. Our District Office, however, is still saying that they do need to comply with the portions that apply to them (Prod / Process Controls). When I read the regulation scope 820.1 (1) it says that component manufacturers are "encouraged to use appropriate provisions of this regulation as guidance".
As several posters in this thread have tried to get across, the third party manufacturer is not legally subject to penalization based on their compliance to the regs. You, however, are subject to penalization based on their compliance to the regs...which you are legally required to control via your contractural relationship with them.

The FDA cannot penalize them, as long as their actions fit within the defined scope of a component manufacturer and they do not conduct specifically regulated activities. The FDA can penalize you if you don't control them effectively.

Certainly the FDA can inspect them if it determines doing so is necessary to verify that the operations they perform are being effectively controlled by you, and are resulting in your regulated products being safe and effective. If it were needed legally, there's plenty of precedent for such inspections of third parties when 21CFR820-required contractural control of that third party is suspected by an inspector to be inadequate, in order to determine whether a product is safe and effective. There's also clear precedent for the FDA applying its judgment, with very few bounds, as to what it needs to do to accomplish its legal mandate.

I am still trying to work with our District Office to ensure that they understand what our relationship is with our manufacturer, as I'm beginning to think it's just been miscommunicated. If not, I am fully prepared to fight with them on this because I can justify our position based on 820.1 (1) and 807.20 (c)(1).
With all due respect, if I were you I'd find a better horse to ride. This one's dead.
 
G

Gerry Quinn

#30
Miregmgr hit the nail on the head. Its all about the Finished Device Manufacturer and his control over his outsourced suppliers.
 
Thread starter Similar threads Forum Replies Date
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
H Obligations as a contract manufacturer during an MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 5
H 510k with Contract Manufacturer Other US Medical Device Regulations 2
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
M We are looking for a Contract Manufacturer US Food and Drug Administration (FDA) 2
L Sample Procedure from Contract Manufacturer Prospective ISO 14971 - Medical Device Risk Management 1
I Is the contract mfg. mentioned in legal manufacturer EC certificate? CE Marking (Conformité Européene) / CB Scheme 4
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R FCC certification (contract manufacturer) TL 9000 Telecommunications Standard and QuEST 1
M Contract manufacturer MDR Quality Management System (QMS) Manuals 1
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
O Identifying KPI for AS9100 8.1.4 - Prevention of Counterfeit Parts - PCB assembly contract manufacturer AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
M Medical Device Master File - We are a contract manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 7
D Software Validation - Contract manufacturer of Components (PCBA's) Qualification and Validation (including 21 CFR Part 11) 7
J Contract Sterilization - Our company is a contract manufacturer Manufacturing and Related Processes 8
R Contract Manufacturer/OEM Supplier - We are a specification developer for a kitted product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site Other Medical Device Regulations World-Wide 0
L REACH Compliance - Small, family-owned contract manufacturer REACH and RoHS Conversations 16
R 21 CFR Part 820 Contract Manufacturer of Medical Device Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Ed Panek Bringing Production in house from Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 80079-34 certified contract manufacturer needed Other ISO and International Standards and European Regulations 2
Ed Panek Observational Audit of Contract Manufacturer Production ISO 13485:2016 - Medical Device Quality Management Systems 5
S Is it okay to store the design files (device drawings) at contract manufacturer location? ISO 13485:2016 - Medical Device Quality Management Systems 6
M Contract Manufacturer of a Finished Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5
D EU MDR - Contract Manufacturer vs Legal Manufacturer EU Medical Device Regulations 4
I Certificate of Exportability - Contract manufacturer located outside the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Is company “A” a contract manufacturer, a labeler, or a repackager 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Integrating a Contract Manufacturer's documentation into our Quality System ISO 13485:2016 - Medical Device Quality Management Systems 3
J Medical Devices sourced from Contract Manufacturers - Who is the legal manufacturer? EU Medical Device Regulations 13
S Question about ISO 13485:2003 - Production Provisions - Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 10
S Contract Manufacturer Question - Whether or not the reference to the ex-CMO ISO 13485:2016 - Medical Device Quality Management Systems 6
R Sterilization Adoption - Design House - Adoption Letter from Contract Manufacturer EU Medical Device Regulations 3
Ajit Basrur Can a Contract Manufacturer Delist a Device upon Discontinuation of Manufacturing? Other US Medical Device Regulations 1
H Who is the Legal / Labeled Manufacturer? (Contract Manufacturers shipping to the EU) ISO 13485:2016 - Medical Device Quality Management Systems 1
N "Sterile" missing on the CE Certificate - ISO 13485 Certified Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 5
N UDI implementation with contract manufacturer Other US Medical Device Regulations 2
somashekar Pre-Announced FDA 4 Day Inspection, Class 2 Devices, Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
W Shared Responsibility Between Spec Provider and Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Device Master Records for a Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
N FDA - Change of Manufacturings Site to Contract Manufacturer in China 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Contract Manufacturer 510K Starting Point 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
P Process Validation of inherited tooling by Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
N Contract Manufacturer EC Certificate Scope ISO 13485:2016 - Medical Device Quality Management Systems 8
S Does Contract Manufacturer need to issue Food Grade certificate for finished device? US Food and Drug Administration (FDA) 1
S Should a contract manufacturer for components be filing MDR exemption? US Food and Drug Administration (FDA) 1
J Import of an Investigational Device from a Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
R Process Development Requirements for a Contract Manufacturer with no Design Design and Development of Products and Processes 5
I Implant Raw Material Supplied from Customer to Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
P Records authorizing release of product at Contract Manufacturer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2

Similar threads

Top Bottom