Ultimately, it is the responsibility of the manufacturer to maintain traceability. It also depends on whether the distributor is buying and reselling or only a logistics point. Regardless, it is typically part of the contract that complete distribution records must be maintained and provided to the manufacturer at regular intervals or upon request. This extends to complaints, feedback, etc. The regulators expectation is on the manufacturer to have a means to trace the product distribution.
Recall notices may direct the public to check the lot number for items on their shelf and discard / return if there are safety or effectiveness issues. Notices should be sent along the supply chain to attempt to reconcile all of the items - of course commensurate with the risk and recall classification.
Original Message:
Sent: 24-Dec-2020 08:17
From: Anonymous Member
Subject: Lot tracking of Single Use PPE
This message was posted by a user wishing to remain anonymous
I think based upon the responses, my question may not have been clear.
I agree if a company is not lot tracking that is a huge red flag!
My question was more around lot tracking through the distribution chain for single use PPE. If companies are using eCommerce platforms, is it expected that say Amazon keep tracks of which customers got which lots? Is that the expectation from regulators?
If not, then are companies just issuing blanket recalls and it is up to the customers to identify if the recall applies to them?
Original Message:
Sent: 23-Dec-2020 16:10
From: Lance Tovar
Subject: Lot tracking of Single Use PPE
Hi,
I'll be blunt. Doesn't matter if the PPE is single use, or not. Your QMS should always be tracking it's supplies. Supplier management should be making sure it's suppliers/vendors/distributors are legitimate and are following all regulations/any applicable standards. If I was auditing a company and discovered the supplies being distributed weren't being labeled, traced, or CofA's were being completed, or anything for that matter, I would consider this a HUGE red flag and deem this supplier as high risk. I know for fact the FDA would issue out a 483.... because like... I've literally seen it happen. Labeling is part of many different ISO and most importantly, part of 21 CFR 820. This would be considered a critical violation.
Hope this helps,
------------------------------
Lance Tovar
RA/QA Specialist
Roy UT
United States
Original Message:
Sent: 22-Dec-2020 13:06
From: Anonymous Member
Subject: Lot tracking of Single Use PPE
This message was posted by a user wishing to remain anonymous
During this pandemic, there are a lot of companies selling PPE, especially on sites like Amazon or other ecommerce platforms.
As many of these PPE items are for single-use only, are there still requirements for tot tracking or are companies just keeping track of customer / distributor information in case of a recall event?
I guess I'm trying to understand what is the 'norm' here.
Regards