предупредувачко писмо

предупредувачко писмо

An informal advisory to a firm communicating the agency's position on a matter but does not commit FDA to taking enforcement action. The agency's policy is that Warning Letters should be issued for violations which are of regulatory significance in that failure to adequately and promptly take corrections may be expected to result in enforcement action should the violation(s) continue.

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писмо

소프트웨어; CRM 애플리케이션

An activity that tracks the delivery of a letter. The activity can contain the electronic copy of the letter.

корекција

생명 과학; 규정

"Correction" means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product and/or the promotional materials which ...

откритие

생명 과학; 규정

The process of obtaining information concerning the other party's case. Methods of discovery are contained in Rule 16 of the Rules of Criminal Procedure, and Rules 26 through 37 ...

повлекување

생명 과학; 규정

A "recall" is a firm's removal or correction of a marketed product(s), including its labeling and/or promotional materials, that FDA considers to be in violation of the laws it ...

отповикување

생명 과학; 규정

Is the cancellation of a license and the withdrawal of the authorization to ship a biological product for sale, barter, or exchange in interstate commerce either at the request of ...

гаранција

생명 과학; 규정

A formal and signed agreement between buyers and sellers in which the latter verifies the goods he sells are not in violation of the FD&C Act when shipped.

меморандум за разбирање

생명 과학; 규정

This is a formal agreement with a state or local agency. The agreement does not involve a transfer of funds or a transfer of personal or real property (Agreements calling for ...