US RAC Practice Exam Update Questions
with Correct Answers Graded A
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[Q] ____ reserve sample(s) from each lot shall be retained for ___ year(s) after expiration date of the last
lot of the drug product containing the active ingredient.
[A] 1. 1
[B] 1. 2
[C] 2. 2
[D] 2. 3 - Answer -[A] 1. 1
[Q] ______ ______ are exempt from the brief summary requirement.
[A]Promotional labeling
[B]Reminder advertisements
[C]Package Inserts
[D]Drug commercials - Answer -[B]Reminder advertisements
[Q] A device user facility must report death to the FDA and manufacturer within __ work days.
[A] 7
[B] 10
[C] 15
[D] 30 - Answer -[B] 10
[Q] Any adverse drug experience occurring at any dose that results in death, threatens life, requires or
prolongs existing hospitalization, or causes persistent or significant disability or incapacity is known as:
[A] Adverse drug experience
[B] Serious adverse drug experience
[C] Serious adulterated drug experience
[D] Reportable event - Answer -[B] Serious adverse drug experience
[Q] Any adverse event associated with the use of a drug, whether or not drug-related, including drug
overdose, drug abuse or withdrawal, and failure of expected pharmacological action is known as:
,[A] Adverse drug experience
[B] Serious adverse drug experience
[C] Serious adulterated drug experience
[D] Reportable event - Answer -[A] Adverse drug experience
[Q] Changes in labeling to an approved NDA are reported in the __________ or _____________?
[A] periodic report, supplemental IDE
[B] quarterly report, supplemental IND
[C] annual report, supplemental NDA
[D] preclinical report, clinical annual report - Answer -[C] annual report, supplemental NDA
[Q] Device complaint records shall be retained for a period of time equivalent to the device's design and
expected life, but in no case less than __ years from the date of release for commercial distribution by
the manufacturer.
[A] 1
[B] 2
[C] 3
[D] 4 - Answer -[B] 2
[Q] Drug complaint records shall be maintained until at least __ year after the expiration date of the drug
product, or __ year after the date the complaint was received, whichever is longer.
[A] 1
[B] 2
[C] 3
[D] 4 - Answer -[A] 1
[Q] Failure to comply with Quality System Regulations renders a device ____________.
[A] Adulterated
[B] Invalid
[C] Illegal
[D] Misbranded - Answer -[A] Adulterated
[Q] How many years is a clinical investigator required to retain case histories following the date of market
approval for the indication?
[A]1
,[B]2
[C]3
[D]4 - Answer -[B]2
[Q] If a device label does not contain quantity of contents, the device is:
[A] Adulterated
[B] Contaminated
[C] Misbranded
[D] Illegal - Answer -[C] Misbranded
[Q] Manufacturers and initial distributors of devices must report adverse experiences within
working____ days of an event requiring remedial action to prevent unreasonable risk of substantial harm
to public health or after becoming aware of a reportable event for which the FDA has made a written
request, or _____calendar days after the manufacturer becomes aware of a reportable event.
[A] 5, 15
[B] 7, 15
[C] 5, 30
[D] 15, 30 - Answer -[C] 5, 30
[Q] Noncompliance with drug advertising regulations or device advertising that promotes an intended
use that is inconsistent with the label will cause the drug or device to be deemed
[A] Adulterated
[B] Invalid
[C] Illegal
[D] Misbranded - Answer -[D] Misbranded
[Q] Periodic reporting of adverse drug experiences must occur _______ for the first _____ years after
approval.
[A] Monthly, 3
[B] Quarterly, 3
[C] Monthly, 2
[D] Quarterly, 2 - Answer -[B] Quarterly, 3
[Q] The Establishment Inspection Report classifies the inspection as one of the following options except
which?
[A] No Action Indicated
, [B] Voluntary Action Indicated
[C] Official Action Indicated
[D] Unofficial Action Indicated - Answer -[D] Unofficial Action Indicated
[Q] The FDA may inspect all of the following except which:
[A] Domestic manufacturing companies
[B] Contract testing laboratories
[C] Contract research organizations (CROs)
[D] Internal audit files - Answer -[D] Internal audit files
[Q] The FDA may not inspect all of the following except which:
[A] Personnel files
[B] Foreign companies
[C] Financial and pricing information
[D] Sales data, except shipment information - Answer -[B] Foreign companies
[Q] The following are included in the 510K application except:
[A] Proposed labeling
[B] Summary or statement
[C] Microbiology
[D] Substantial Equivalent information - Answer -[C] Microbiology
[Q] Types of FDA inspections include all of the following except which?
[A] GPP compliance
[B] GMP/QSR compliance
[C] GLP compliance
[D] GCP compliance - Answer -[A] GPP compliance
[Q] Upon receipt of the 483 form, the manufacturer has __ working days to respond, in writing, with a
detailed corrective action plan.
[A] 15
[B] 30
[C] 45
[D] 60 - Answer -[A] 15
with Correct Answers Graded A
Download (100 out of 100%)
[Q] ____ reserve sample(s) from each lot shall be retained for ___ year(s) after expiration date of the last
lot of the drug product containing the active ingredient.
[A] 1. 1
[B] 1. 2
[C] 2. 2
[D] 2. 3 - Answer -[A] 1. 1
[Q] ______ ______ are exempt from the brief summary requirement.
[A]Promotional labeling
[B]Reminder advertisements
[C]Package Inserts
[D]Drug commercials - Answer -[B]Reminder advertisements
[Q] A device user facility must report death to the FDA and manufacturer within __ work days.
[A] 7
[B] 10
[C] 15
[D] 30 - Answer -[B] 10
[Q] Any adverse drug experience occurring at any dose that results in death, threatens life, requires or
prolongs existing hospitalization, or causes persistent or significant disability or incapacity is known as:
[A] Adverse drug experience
[B] Serious adverse drug experience
[C] Serious adulterated drug experience
[D] Reportable event - Answer -[B] Serious adverse drug experience
[Q] Any adverse event associated with the use of a drug, whether or not drug-related, including drug
overdose, drug abuse or withdrawal, and failure of expected pharmacological action is known as:
,[A] Adverse drug experience
[B] Serious adverse drug experience
[C] Serious adulterated drug experience
[D] Reportable event - Answer -[A] Adverse drug experience
[Q] Changes in labeling to an approved NDA are reported in the __________ or _____________?
[A] periodic report, supplemental IDE
[B] quarterly report, supplemental IND
[C] annual report, supplemental NDA
[D] preclinical report, clinical annual report - Answer -[C] annual report, supplemental NDA
[Q] Device complaint records shall be retained for a period of time equivalent to the device's design and
expected life, but in no case less than __ years from the date of release for commercial distribution by
the manufacturer.
[A] 1
[B] 2
[C] 3
[D] 4 - Answer -[B] 2
[Q] Drug complaint records shall be maintained until at least __ year after the expiration date of the drug
product, or __ year after the date the complaint was received, whichever is longer.
[A] 1
[B] 2
[C] 3
[D] 4 - Answer -[A] 1
[Q] Failure to comply with Quality System Regulations renders a device ____________.
[A] Adulterated
[B] Invalid
[C] Illegal
[D] Misbranded - Answer -[A] Adulterated
[Q] How many years is a clinical investigator required to retain case histories following the date of market
approval for the indication?
[A]1
,[B]2
[C]3
[D]4 - Answer -[B]2
[Q] If a device label does not contain quantity of contents, the device is:
[A] Adulterated
[B] Contaminated
[C] Misbranded
[D] Illegal - Answer -[C] Misbranded
[Q] Manufacturers and initial distributors of devices must report adverse experiences within
working____ days of an event requiring remedial action to prevent unreasonable risk of substantial harm
to public health or after becoming aware of a reportable event for which the FDA has made a written
request, or _____calendar days after the manufacturer becomes aware of a reportable event.
[A] 5, 15
[B] 7, 15
[C] 5, 30
[D] 15, 30 - Answer -[C] 5, 30
[Q] Noncompliance with drug advertising regulations or device advertising that promotes an intended
use that is inconsistent with the label will cause the drug or device to be deemed
[A] Adulterated
[B] Invalid
[C] Illegal
[D] Misbranded - Answer -[D] Misbranded
[Q] Periodic reporting of adverse drug experiences must occur _______ for the first _____ years after
approval.
[A] Monthly, 3
[B] Quarterly, 3
[C] Monthly, 2
[D] Quarterly, 2 - Answer -[B] Quarterly, 3
[Q] The Establishment Inspection Report classifies the inspection as one of the following options except
which?
[A] No Action Indicated
, [B] Voluntary Action Indicated
[C] Official Action Indicated
[D] Unofficial Action Indicated - Answer -[D] Unofficial Action Indicated
[Q] The FDA may inspect all of the following except which:
[A] Domestic manufacturing companies
[B] Contract testing laboratories
[C] Contract research organizations (CROs)
[D] Internal audit files - Answer -[D] Internal audit files
[Q] The FDA may not inspect all of the following except which:
[A] Personnel files
[B] Foreign companies
[C] Financial and pricing information
[D] Sales data, except shipment information - Answer -[B] Foreign companies
[Q] The following are included in the 510K application except:
[A] Proposed labeling
[B] Summary or statement
[C] Microbiology
[D] Substantial Equivalent information - Answer -[C] Microbiology
[Q] Types of FDA inspections include all of the following except which?
[A] GPP compliance
[B] GMP/QSR compliance
[C] GLP compliance
[D] GCP compliance - Answer -[A] GPP compliance
[Q] Upon receipt of the 483 form, the manufacturer has __ working days to respond, in writing, with a
detailed corrective action plan.
[A] 15
[B] 30
[C] 45
[D] 60 - Answer -[A] 15
