Warning letter addresses lack of training/education

AnaMariaVR2

Trusted Information Resource
#1
A quick look at the FDA's warning letters site led me to this:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm219001.htm

A warning letter to Abbott Diabetes Care, Inc. from 7/2/10


I wanted to share this here because industry have the tendency of hiring QA/Regulatory personnel without the adequate science qualification and hence it effects the quality of the product in the chain.

Anyone can subscribe to updates to the warning letters, they are not a secret. In fact, perusing the warning letters gives one FDA's current thinking, and what they're really scrutinizing in their audits. Very educational! :yes:

It's very important for QA/regulatory professional to have adequate Science-Analytical-Method development experience (not a sole law background for RA) and FDA regulatory requirements for Brand and Generic industry. FDA's current thinking may prompt many firms to take action...the foundation of all these laws is the science behind them. I'm happy to see a science-driven FDA...hopefully all this leads to better quality.

Any thoughts or comments?
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Warning letter addresses lack training/education

Thank you for sharing this interesting letter. :applause::thanks:

As QA professionals the question of extent of power and responsibility rises to the forefront. As an Internal Auditor I find this letter especially instructive because to date I haven't audited HR to this depth: do personnel assigned to critical positions have the qualifications to adequately perform as needed to achieve the company's goals? (in this case it's compliance for continuation of sales within FDA requirements). This letter suggests that I should audit to such depth, or at least keep my nose sensitive so to speak, and if I get a sense there's something amiss during an audit I should indeed excavate to this degree.

As an internal auditor I sometimes grapple with what requirements would suffice in convincing process owners and resourcing managers that a change is needed - that my finding is relevant. FDA letters and OSHA letters of definition are useful in pressing a case or supporting my interpretation of the law or code. Since I have more than once declared I am happy when my people push back about my findings because it shows they are thinking about the QMS, it's in my interest to be ready for such pushback with real life examples of why following requirements is important.

Thanks again!
 
A

achorste

#4
Keeping up to date with these warning latters is sometimes agreed to be part of keeping "current" with cGMP, you can sign up to an email services that sends through updates every week including warning letters. The MHRA have a similar service in the UK.

This warning letter in particular raised my interest, not just for medical devices but generally in manufacturing / service provision, looking at how the organisation determines what makes a person competent to do a job and how they are assessed against that competence.

In this instance, the job descriptions didn't match the people performing that role - does that make those people "not competent"? More likely the competency requirements were poorly constructed.
 

Scott Catron

True Artisan
Super Moderator
#5
I wanted to share this here because industry have the tendency of hiring QA/Regulatory personnel without the adequate science qualification and hence it effects the quality of the product in the chain.
Actually it seems like the company was written up for not following their own procedures. It was the company-produced job description that called for the science degree, not a directive from the FDA.

The warning letter referenced 21 CFR 820.25(a): "Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed."

That's it. Nothing about science degrees - the company decides what to include in the job description.

Just because someone doesn't have a science-based degree doesn't mean they can't run a medical device QA department.
 
#8
A quick look at the FDA's warning letters site led me to this:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm219001.htm

A warning letter to Abbott Diabetes Care, Inc. from 7/2/10


I wanted to share this here because industry have the tendency of hiring QA/Regulatory personnel without the adequate science qualification and hence it effects the quality of the product in the chain.

Anyone can subscribe to updates to the warning letters, they are not a secret. In fact, perusing the warning letters gives one FDA's current thinking, and what they're really scrutinizing in their audits. Very educational! :yes:

It's very important for QA/regulatory professional to have adequate Science-Analytical-Method development experience (not a sole law background for RA) and FDA regulatory requirements for Brand and Generic industry. FDA's current thinking may prompt many firms to take action...the foundation of all these laws is the science behind them. I'm happy to see a science-driven FDA...hopefully all this leads to better quality.

Any thoughts or comments?
Say what you do, and do what you say...it's really that simple.

It has nothing to do with science.
 
M

mad_casual

#9
Say what you do, and do what you say...it's really that simple.

It has nothing to do with science.
Really? So if the doc says, "breathing + pulse = qualified", that's cool?

Not to hate on 'non-science' people, more asking as scientist working in a company where they would just rewrite the docs to lower standards without caring what that did to product quality.
 
K

KilgoreTrout

#10
Actually it seems like the company was written up for not following their own procedures. It was the company-produced job description that called for the science degree, not a directive from the FDA.

The warning letter referenced 21 CFR 820.25(a): "Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed."

That's it. Nothing about science degrees - the company decides what to include in the job description.

Just because someone doesn't have a science-based degree doesn't mean they can't run a medical device QA department.
This.

The firm's own procedures, including the job descriptions on file, listed the requirements for those functions. Then the firm didn't follow their own documents.

I wanted to share this here because industry have the tendency of hiring QA/Regulatory personnel without the adequate science qualification and hence it effects the quality of the product in the chain.
The OP took one item of the warning letter out of context and made a broad "sky is falling" generalization. Fail.

Mad casual - it's up to the firm to define requirements for any position. If respiration and pulse are all that's required by the job description, then that's the minimum. The CFR makes general statements about suitable level of education/experience for those responsible for product acceptance and other functions, and in those cases FDA would have a good argument for more robust requirements in the job description, but it's still up to the firm to define.
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
P Warning Letter 1999 - Where does the FDA make older warning letters available? US Food and Drug Administration (FDA) 4
H Most Poorly Written FDA Warning Letter Ever? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
J FDA 483 Warning Letter for use of Calipers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
T FDA Form 483 Warning Letter - What next? US Food and Drug Administration (FDA) 7
S FDA Warning Letter Remediation - Enforcement Resolution & Remediation Process US Food and Drug Administration (FDA) 3
L Warning Letter adressed to owner/operator or facility? US Food and Drug Administration (FDA) 1
AnaMariaVR2 Agila Specialties Private Limited Warning Letter US Food and Drug Administration (FDA) 0
S FDA Warning Letter on Medical Device Reporting Interpretation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
AnaMariaVR2 Jubilant HollisterStier General Partnership [warning letter] US Food and Drug Administration (FDA) 1
M FDA Warning Letter - Product Association with Search Engine Results - Problems Ahead? US Food and Drug Administration (FDA) 10
AnaMariaVR2 St. Jude Medical does the unthinkable: Warns of FDA warning letter before FDA issues US Food and Drug Administration (FDA) 5
AnaMariaVR2 Warning Letter to Fercy Personal Care Products - company kicked out FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
A FDA 483 Warning Letter Response Time Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
AnaMariaVR2 FDA writes up Warning Letter to British Homeopathic Drugmaker US Food and Drug Administration (FDA) 0
Y Siemens Healthcare - FDA Warning Letter Analysis 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M MDR Rules Change Revealed in Warning Letter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
A FDA Audit Documentation - Recently released FDA Warning Letter Qualification and Validation (including 21 CFR Part 11) 9
AnaMariaVR2 Anulex sees layoffs after FDA warning letter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A How long does it take US FDA to issue a Warning Letter Close Out Letter Other US Medical Device Regulations 2
AnaMariaVR2 Cordis CAPA Warning Letter US Food and Drug Administration (FDA) 0
AnaMariaVR2 Shocking Warning Letter - Baxter Healthcare Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
E How to Respond to a US FDA untitled letter - Form 483 or Warning Letter Other US Medical Device Regulations 2
C The warning letter of ONBO - Why FDA require identification of 510(k) ownership? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C 510(k) Issuance & Warning Letter - to spec. developer or contract manufacturer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Warning! Rude & Crude Content! Complaint Letter Coffee Break and Water Cooler Discussions 17
G Warning about Deltronic Gage Pins - The "Certification of Accuracy" document General Measurement Device and Calibration Topics 13
W IMDS - Help (Common Warning and Error Fixes) RoHS, REACH, ELV, IMDS and Restricted Substances 9
N IMDS Warning Polymer Material Two Substances RoHS, REACH, ELV, IMDS and Restricted Substances 8
J Employer Warning Notice a Controlled Document? Document Control Systems, Procedures, Forms and Templates 7
9 EU Medical Device Manufacturer Warning Letters EU Medical Device Regulations 2
W Medical Device Warning Lights Colors IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
AnaMariaVR2 Warning ? Don?t Confuse ?Made In USA? And ?Inspected By FDA? With Patriotism US Food and Drug Administration (FDA) 3
AnaMariaVR2 Gilead plant joins the FDA's "warning club" US Food and Drug Administration (FDA) 0
K Where you can read other companys' 483 FDA Warning Letters 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
I IMDS Warning - Chromate Filming of Zinc Plating RoHS, REACH, ELV, IMDS and Restricted Substances 4
AnaMariaVR2 FDA Global Clampdown: 8 Warning Letters - Failing to Register Plants US Food and Drug Administration (FDA) 0
D Appropriate Statistical Methods to set up an Alert/Warning Limit Quality Assurance and Compliance Software Tools and Solutions 15
AnaMariaVR2 FDA issued Warning Letters to Beckman Coulter - 2011 US Food and Drug Administration (FDA) 1
Ajit Basrur FDA issues Warning Letters for misleading advertising of Lap-Band US Food and Drug Administration (FDA) 3
T FMEA Severity 9 &10 - Example of "with warning?" FMEA and Control Plans 6
AnaMariaVR2 The Top 12 FDA 2011 Warning Letters Report US Food and Drug Administration (FDA) 7
AnaMariaVR2 FDA has issued three Warning Letters... US Food and Drug Administration (FDA) 13
C Cleanroom Class 8 (100,000) Particulate Control and Warning Limits Statistical Analysis Tools, Techniques and SPC 1
AnaMariaVR2 4 API Warning Letters focusing on Laboratory Practices US Food and Drug Administration (FDA) 0
F Breakdown and Analysis of FDA Warning Letters US Food and Drug Administration (FDA) 11
Jim Wynne Glass-top Patio Tables Shatter Without Warning Coffee Break and Water Cooler Discussions 14
V Evidence for Preventive Action & Early Warning Vigilance procedure Preventive Action and Continuous Improvement 4
L Risk of Bodily Harm - Warning vs. Caution Statements on Medical Device Labeling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B ISO 14971 DFU IFU Warning Adding Accessory ISO 14971 - Medical Device Risk Management 1

Similar threads

Top Bottom