Is it a requirement to notify my customer if I receive a 483 from the FDA?

RCW

Quite Involved in Discussions
#1
I am a contract manufacturer of medical devices.

Is it a requirement to notify my customer if I receive a 483 from the FDA?
If so, if the 483 pertains to one customer's medical device but not another, do I need to notify that other customer?

Are there any good links that would address this?
 
Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#3
I agree with Ajit. ...But if this is not clear in a formal agreement, though not a requirement elsewhere, as a customer I would probably appreciate being kept in the loop.

FDA 483 observations are not uncommon, and shouldn't be a deal-breaker, provided you've got plans for addressing them (or justification not to).

As you draft a response to the FDA (which you are presumably doing), perhaps also send the response to the customer. That way, the customer is aware of the observations, and that you are being diligent in addressing them.

Ultimately, keep your customer-relationship in mind, and do what is prudent. If the observations are minor and quickly fixed, maybe don't bother. If the observations could affect the product you are (and have been) delivering, then the customer would probably appreciate knowing...
 
Last edited:
L

lfrost

#4
I agree with what both above have said. You must remember that with the FDA whenever they inspect, they always leave a 483. They will always find something to list on it. Your customer should realize this and that you will make the necessary corrections to your quality system.

FWIW: We just had our FDA Inspection and the inspector left us with only three observations on the 483. All three were minor, two were about the Training we have and didn't document, the other was concerning three resolved corrective actions that didn't list the root cause.

So I really don't think you nor your customer should really worry about the 483 observations. Just hope you do not receive a Written Warning Letter which becomes public record!
 
M

MIREGMGR

#5
If I'm your customer, I'm the ultimate party at risk. FDA could shut down your manufacturing of my products, or require a recall of my products. The latter in particular could damage my market reputation and cost me a ton of money.

If I'm your customer and you don't tell me immediately, either you've violated my quality agreement with you, which should require immediate communications of such a situation; or I've done an incompetent job of contractually defining our relationship, which is a regulatory obligation of mine.

If you don't tell me immediately, I won't know that my technical and quality supervision of your manufacturing has been incompetent, in that it didn't spot whatever the FDA inspector cited you for.

Until you tell me, I won't know that I'm exposed to issuance of a Warning Letter to me, even though it was you that was inspected, for fundamental 21CFR 820 supplier control violations.

Beyond that, if you don't tell me immediately, you've shown me that we have a relationship in which you think it's desirable or necessary to hide information from me regarding quality issues (whatever was cited on the 483) and regulatory issues (the fact of the inspection and 483 issuance).

If you tell me immediately, I might keep you as a supplier, depending on the circumstances. If you don't, you're gone as soon as I can make another arrangement.
 

RCW

Quite Involved in Discussions
#6
Currently I do not have any 483s issued against my company. In fact, during the last FDA audit about 3 years ago, no 483s were issued at all. :)

I had a medical device customer inquire about not addressing flowing 483 results back to them. After pulling out their quality agreement, they require this. I pulled quality agreements out from two other medical device customers and they did not require the results.

My quest was to determine if there was a standard flowing down this requirement to me. From the good information that has been posted here, it appears to be coming solely from the quality agreement.

I've only had a couple of 483 issued and they were general in nature. It was my concern if the 483 ever included product specific information that a different customer should not have access to (nondisclosure violation). If they are kept in a general, systemic format, then the 483 can and should be freely shared with all my customers.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Currently I do not have any 483s issued against my company. In fact, during the last FDA audit about 3 years ago, no 483s were issued at all. :)

I had a medical device customer inquire about not addressing flowing 483 results back to them. After pulling out their quality agreement, they require this. I pulled quality agreements out from two other medical device customers and they did not require the results.

My quest was to determine if there was a standard flowing down this requirement to me. From the good information that has been posted here, it appears to be coming solely from the quality agreement.

I've only had a couple of 483 issued and they were general in nature. It was my concern if the 483 ever included product specific information that a different customer should not have access to (nondisclosure violation). If they are kept in a general, systemic format, then the 483 can and should be freely shared with all my customers.
If there are confidentiality issues you could always mask out the client-specific info, and explain that when you communicate the 483. Maybe even worth mentioning in the quality agreement upfront, to avoid surprises and unnecessary debates down the track.
 
Thread starter Similar threads Forum Replies Date
K 510 (k) - Requirement to notify the FDA or is only the Notified Bodies required? Registrars and Notified Bodies 1
A The requirement of the PMS plan--suitable indicators and threshold values EU Medical Device Regulations 0
S Battery powered device - electrical protection requirement IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
K Regulatory requirement of SaMD with machine learning component IEC 62304 - Medical Device Software Life Cycle Processes 2
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
P Regulatory or registration requirement for disinfectant in ASEAN Registrars and Notified Bodies 1
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
W Misinterpretation of requirement acceptable as root cause? Problem Solving, Root Cause Fault and Failure Analysis 19
S ECG Cable Banana to Snap or Tab electrode Adapters -- ISO 10993 Requirement Other Medical Device Related Standards 0
D IATF 16949 Requirement for CMMI in a Global Company Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
W Regarding Requirement for Hi pot & Leakage Current test Station Set-up IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
L Stage 2 audit - Requirement for 3 months of records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Requirement to manufacture under a quality management system EU Medical Device Regulations 4
A Risk Number for each software requirement IEC 62304 - Medical Device Software Life Cycle Processes 7
T ISO 17025:2017 requirement 5.7.b. about maintenance the integrity of the management system ISO 17025 related Discussions 1
I Laboratory Fridge / Freezer Inventory - Requirement(s) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Several sections of traditional 510(K) have the same or similar requirement of content. US Food and Drug Administration (FDA) 4
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
C Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery ISO 17025 related Discussions 4
Q User Requirement Specification for HR (Human Resource Management System) Manufacturing and Related Processes 1
P Obstruction alarm requirement ISO 80601-2-12 Other Medical Device Related Standards 1
P Electrosurgical Device User Need: Cord Flexibility -> Requirement Other Medical Device and Orthopedic Related Topics 4
C Industrial scales and MSA (IATF 16949 requirement 7.1.5.1.1) IATF 16949 - Automotive Quality Systems Standard 30
C ISO 13485 Requirement in Australia/NZ for class 1? ISO 13485:2016 - Medical Device Quality Management Systems 1
N Label Placement Requirement in MDD/MDR EU Medical Device Regulations 1
adir88 MDR requirement: Risk Management Plan for "each device" ISO 14971 - Medical Device Risk Management 5
S Article 61 - MDR Clinical Investigation Requirement EU Medical Device Regulations 5
V 3 PQ lots mentioned as requirement in PPAP. Is this necessary? APQP and PPAP 2
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Clinical Evaluation - Is this an ISO 13485:2016 requirement? ISO 13485:2016 - Medical Device Quality Management Systems 4
S ISO17020 - Equipment calibration requirement General Measurement Device and Calibration Topics 3
A ISO 17025 Requirement 6.2 - Department Manager Testing Qualifications ISO 17025 related Discussions 1
F Process Review - What is the ISO requirement for reviewing SOPs and quality documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
shimonv IEC 60601-1 Essential Performance - Is the signal accuracy specification an essential requirement? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Ronen E Can anyone please explain this? (510k submission requirement) Other US Medical Device Regulations 14
M EU MDR - Annex II 3b - What documents fall under this requirement? EU Medical Device Regulations 3
D Vietnam requirement of CE mark for medical devices CE Marking (Conformité Européene) / CB Scheme 4
C Does ISO 9001-2015 have a requirement for manufacturing equipment to be numbered? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
L Gage R&R studies for identical Devices - Need to confirm the requirement to perform them Reliability Analysis - Predictions, Testing and Standards 2
A Microbial exposure during use - Requirement 11.1(c) EU Medical Device Regulations 1
D Requirement of Pharmacovigilance (Drug Safety) Risk Based Strategic and Tactical Audit Plan General Auditing Discussions 0
S Device name change and label color change EU requirement? Other Medical Device Regulations World-Wide 6
I Receiving Inspection Requirement in IATF IATF 16949 - Automotive Quality Systems Standard 3
C ISO 17025 2017, Requirement 6.6.3 - Communicate requirements to external providers ISO 17025 related Discussions 4

Similar threads

Top Bottom