FDA QMSR Inspection Quiz 8b. FDA QMSR Inspection This is a pop quiz for the FDA QMSR Inspection lesson. PhoneThis field is for validation purposes and should be left unchanged.Name First Last Company Company Name Title Email PhonePlease answer the following questions by checking the appropriate option. You are permitted to look up answers for this quiz (i.e., “open book” and “open notes”). A passing score is 3 out of 4 questions correct. After completing this quiz, the final result will be displayed on the screen. Save the information on the screen as your training record for the successfully completing the quiz. You will also receive an email of your results. That email can also be used as part of your training record.1. What does the number “483” refer to in the context of FDA inspections?(Required) the applicable clause in the ISO Standard the form number inspectors use to record inspection observations the reference to the FDA regulation number the number of inspection observations identified in 2020 2. Non-US Companies will be placed on “Import Detention” and may not ship product into the USA after receiving how many Warning Letters?(Required) Four One Two Three 3. Which section of the regulations results in the most inspection findings each year?(Required) 21 CFR 820.181 (DMR) 21 CFR 820.50 (Purchasing) N/A – the findings are randomly distributed between the sections each year 21 CFR 820.100 (CAPA) 4. FDA inspectors may take copies with them from an inspection.(Required) True False Δ
