RAC Matrix Test Bank Complete Questions and Correct Answers (Verified Answers) 2024 Latest Update
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RAC Matrix
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RAC Matrix
RAC Matrix Test Bank Complete Questions and Correct Answers (Verified Answers) 2024 Latest Update
[Q]The following are adverse drug experience except:
[A]Use of drug in professional practice
[B]Drug overdose
[C]Drug abuse or withdrawal
[D]Birth defect - Answer- [D]Birth defect
[Q]For ...
RAC Matrix Test Bank Complete
Questions and Correct Answers
(Verified Answers) 2024 Latest
Update
[Q]The following are adverse drug experience except:
[A]Use of drug in professional practice
[B]Drug overdose
[C]Drug abuse or withdrawal
[D]Birth defect - Answer- [D]Birth defect
[Q]For drugs, periodic reports must be submitted to the agency:
[A]monthly for the first 2 years after market approval
[B]quarterly for the first 3 years after market approval
[C]semi-annually for the first 4 years after market approval
[D]annually for the first 5 years after market approval - Answer- [B]quarterly for the first
3 years after market approval
[Q]Types of inspection for routine or for cause are the following except:
[A]GMP/QSR compliance
[B]GLP compliance
[C]GCP compliance
[D]ISO compliance - Answer- [D]ISO compliance
[Q]Upon receipt of 483, how many days does a sponsor have to respond to FDA:
[A]5 work days
[B]10 calendar days
[C]15 calendar days
[D]15 work days - Answer- [D]15 work days
[Q]For sterile devices, what type of test is required before market release:
[A]Verification test
[B]Validation test
[C]Quality test
[D]Sterility test - Answer- [D]Sterility test
[Q]For drugs and biologics, lot must comply with release as negotiated in:
[A]cleared IND
[Q]For drugs, what unit performs the sampling and testing of batches to ensure it meets
the specification and statistical criteria prior to release:
[A]Quality Assurance
[B]Quality Control
[C]Quality Inspectors
[D]Release Testers - Answer- [B]Quality Control
[Q]If vaccine is subject to lot release, lots cannot be distributed until they are released
by:
[A]CDRH
[B]OGD
[C]CDER
[D]CBER - Answer- [D]CBER
[Q]How many days of an FDA request, before distribution of a tracked device to a
patient, the distributor name and contact information of the distributors and the location
of the device:
[A]3 working days
[B]3 calendar days
[C]5 working days
[D]10 working days - Answer- [A]3 working days
[Q]How many days of an FDA request, after distribution or implantatio, the UDI or other
identifier, date shipped and date to patient, patient and physician information:
[A]3 working days
[B]3 calendar days
[C]10 working days
[D]10 calendar days - Answer- [C]10 working days
[Q]What act adds a mandate to implement an electronic track and trace system to
identify and trace certain presciption drugs throughoutthe US supply chain:
[A]Tracking of Drugs and Biologics Act
[B]Distribution of Prescription Drug Act
[C]Transportation Security Act
[D]Drug Suppy Chain Security Act - Answer- [D]Drug Suppy Chain Security Act
[Q]Reserve sample consists of at least _____ the quantity necessary for all tests
required.
[A]double
[B]triple
[C]half
[D]quarter - Answer- [A]double
, [Q]Retention time of active ingredient is _______ after expiration date of the last lot of
the drug product containing the active ingredient.
[A]one year
[B]two years
[C]three years
[D]four years - Answer- [A]one year
[Q]All US medical regulations must be met by foreign establishments in order to import
products except:
[A]establishment registration
[B]device listing
[C]QSR manufacturing
[D]GMP manufacturing
[E]MDR
[F]510k or PMA - Answer- [D]GMP manufacturing
[Q]Devices approved to be marketed in US may be exported in the world with prior FDA
notification or approval:
[A]True
[B]False - Answer- [B]False
can be exported without prior FDA notification or approval
[Q]All devices to be exported that are not cleared for marketing in US must adhere to
the following except:
[A]Meet the purchaser's specifications
[B]Not conflict with the importing country's laws
[C]Can be sold in domestic commerce
[D]May require certificate of Exportability or certificate of foreign government - Answer-
[C]Can be sold in domestic commerce
[Q]What device class require FDA approval to export:
[A]Class I
[B]Class II cleared
[C]Class III without PMA
[D]Class III with PMA - Answer- [C]Class III without PMA
[Q]New drug may be imported if it is the subject of an:
[A]approved OTC
[B]cleared IDE
[C]cleared IND
[D]approved NDA - Answer- [D]approved NDA
[Q]What is the prerequisite to a Warning Letter?
[A]481
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