Skip survey header

Compliance Quiz: FDA Inspections

1. Which of the following in NOT a type of FDA inspection?
2. Fill in the blanks: Under the Food, Drug and Cosmetic Act (21 USC §374), Section 704, 21 CFR 312.68, and 21 CFR 812.145, the FDA has the authority "to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices or cosmetics are …___________, ____________,___________, or_________. "
3. Which of the following is NOT an FDA Enforcement Action:
4. Which of the following is NOT a common field inspection form:
5. "The observations noted in this Form FDA-483 [sic] are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting ___________ __________to identify and correct any and all violations of the quality system requirements."
6. Whereas the Form 483 Notice of inspectional observations does not represent a final Agency determination regarding your compliance, a Warning letter differs from a 483 in that it:
  • This question is required
0%