Definition Legal Hold Notice - What is a Legal Hold Notice?

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MIREGMGR

#2
FDA can order that medical devices be held rather than distributed until some requirement is satisfied. A "hold order" could be used to describe that situation.

Customs & Border Protection also can put goods into hold status.

I would assume that in other countries and regulatory jurisdictions, regulators and customs authorities have similar powers.
 

SGquality

Quite Involved in Discussions
#3
Thanks MIREGMGR. Yes I understand that Hold from commercial distribution b ut one of our customers was talking mainly from a "preservation" angle as applicable for product and documents. I have asked for more details.

Btw, is there any legal hold system from a document preservation standpoint for actual or "probable" litigation ?
 

Wes Bucey

Quite Involved in Discussions
#4
Thanks MIREGMGR. Yes I understand that Hold from commercial distribution b ut one of our customers was talking mainly from a "preservation" angle as applicable for product and documents. I have asked for more details.

Btw, is there any legal hold system from a document preservation standpoint for actual or "probable" litigation ?
Without complete information, we can only guess.

A potential plaintiff may serve a notice to "hold" (not destroy or discard) data or products which may be subject to dispute (criminal or commercial) which may subsequently be resolved through court decision, negotiation, or formal arbitration. The party may STILL discard or destroy, but they leave themselves open to directed verdicts from courts. "Legal hold" usually means either government agencies or courts are involved. Some examples of non-government or court reasons to "hold" (usually only products and allied shipping and inspection documents) from a supplier's viewpoint first, then from customer's:
Customer says, "Product fails incoming inspection and we will ship back at supplier's expense." [maybe there is a dispute as to whether the product really failed or customer is changing requirements in midstream because of some economic reason unrelated to quality in an attempt to shift financial burden to supplier.) Supplier says, "Hold shipment for 3rd party inspection!"

Supplier says, "Customer hasn't paid for last shipment, so carrier (truck, train, plane) should hold and not deliver until further notice." OR "We have discovered a glitch in our system and do not know yet if it affects products already delivered. Please put on temporary hold and do not use in manufacture until decision whether recall is warranted."

Customer says, "We have design change in discussion. Please suspend production and hold current inventory. Do not ship until we determine whether to scrap, remanufacture, or use as is at our expense."

Customer says, "Roof collapsed on our warehouse from storm. Hold shipments until notice of repair or alternate location."
 
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