Supplier Issued FDA Warning Letter

Hi Guys!

I am revamping our Approved Supplier Program and I ran into a question that I would love to hear some feedback on.

I always run potential suppliers through the FDA Warning Letter/ Recall database to see if any red flags pop up. So far I have not found anything to worry about. 

However,if  I would ever find out a supplier has had an FDA warning letter issued recently (for GMP/Cleaning issues for example) what would the recommended steps be in order to verify the issue has now been corrected, and they are safe to purchase from?

If the FDA closes out the issue can it be assumed the issue was corrected and it is not an issue anymore or should a potential customer still perform their own verification by possible visiting the facility, sending raw ingredient samples out for COA verification, conducting a Customer Audit, etc?

Also, if an APPROVED supplier would ever be issued a warning letter, are there certain steps customers need to complete before re-ordering?

Any feedback would be great, Thanks!

I haven't ever ran into this but my quality manager at my last factory said she had... she didn't really say anything much about it.

I would reach out to them with my concerns and reference the violation and ask them if it impacted any of my ingredients/products.  Ask what was found, if the warning letter didn't spell it out, and what their corrective action plan is to remedy the situation.  I would also ask them to send me the response they sent the FDA and any of their supporting information.

Even if the FDA closed it out I wouldn't just assume anything.  How many places can fake an entire audit (clean, doctor forms, etc).  I would still go out to them and ask for information and maybe go there an inspect their operation if I felt I needed to.

You need to protect yourself and I really don't trust anyone :eek_yello:

I agree with Mr Incognito.  There was a saying of US President Reagan's that applies here. “Doveryai, no proveryai,”Trust, but verify" 

I would go through all the steps Mr. I listed and also ask them for a GFSI audit if possible or at least a reputable 3rd Party Audit done since the FDA Warning Letter. 

I agree with Mr Incognito.  There was a saying of US President Reagan's that applies here. “Doveryai, no proveryai,”Trust, but verify" 

 

HA! I have that printed on the page stuck in the front of the internal auditors binders that has the information they need to do audits.  Ofc it has the actual Russian letters

Доверяй, но проверяй

now that I've posted that I hope that someone from Russia doesn't laugh and say "That's not what that says" lol

I wouldn't worry at all since FDA is very hard to pass. If you don't comply, you are in trouble.  

Dear QAMgr,

The sensitivity may relate to yr sphere of business (?)

I'm not in USA but this FDA special seems to cover an enormous range of proven/perceived defects -

http://en.wikipedia...._Warning_Letter

Some of the, i suspect, examples of such which I have seen on the IT suggest that the recipient either never implemented any substantial QA at all or the existing version is hopelessly inadequate or collapsed. I imagine that the minor ones never reach the IT.

The point is that yr own reaction may well be case-by-case, eg not touch with a barge-pole or possibly ignore. In between these extremes suggests an audit, eg questionaire/direct depending on policy, situation,etc. 

Or perhaps you are, or are obliged to be, highly risk-averse. This will likely up the risk assessment/likelihood-severity of action.

Rgds / Charles.C

Great points made by all. Your points confirmed what I originally thought: verify, verify, verify. 

I will be adding a section in our Supplier Approval Evaluation Process requiring the following items for any supplier that has had an FDA Warning/Recall issued within the last 2 years:

1. A successful third party audit since the violation was posted.

2. A copy of the corrective actions and their statuses relating to the specific incident

3. The expected FDA re-inspection date ( or a copy of the report if it already was completed)

If the supplier fails to supply sufficient information, and it is not applicable to order the specific raw material from another reputable supplier, than a Customer Tour/Facility Inspection will be requested prior to first shipment. 

Thanks again for the feedback everyone. 

HA! I have that printed on the page stuck in the front of the internal auditors binders that has the information they need to do audits.  Ofc it has the actual Russian letters

Доверяй, но проверяй

now that I've posted that I hope that someone from Russia doesn't laugh and say "That's not what that says" lol

I did consider writing my Quality Manual in Welsh......

You'd save a ton on vowels!  :shades: