Regulatory

Regulatory

Industry: Life Sciences

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Regulatory

Summary and recommendation (s& r)

Life Sciences; Regulatory

The written justification from the District in its request for institution of a criminal prosecution.

Supervisory charges

Life Sciences; Regulatory

The charges for supervising the reconditioning and examination of articles that an importer, owner, or consignee attempts to bring into compliance after detention (See 21 CFR 1.99).

Temporary restraining orders are court-enforced cease and desist orders that are brought to control an emergency situation. A TRO seeks immediate, temporary relief (for a period of 10 days, which may ...

Triple damages

Life Sciences; Regulatory

For FDA regulated products, the amount of liquidated damages assessed by Customs against the lot(s) not redelivered upon Customs demand is, at this printing, triple the amount of the lot value used ...

Warning letter

Life Sciences; Regulatory

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 ...

Procedure in admiralty

Life Sciences; Regulatory

Seizure actions taken pursuant to the FD&C Act are (per Section 304(b)) to be in conformity with the procedure in admiralty, which means the Government may initiate confiscation of articles it deems ...

Recall

Life Sciences; Regulatory

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