10 Questions
What type of facilities does the FDA inspect to ensure compliance with regulations?
Various types including blood banks, food processing facilities, and clinical trial laboratories
In what situations would the FDA conduct a for-cause inspection?
To investigate a specific problem brought to the FDA's attention
What type of records of inspections does the FDA make available to the public?
Certain frequently requested records in an electronic reading room
Which section of 21 CFR 211 deals with the testing and release for distribution of drug products?
211.165-Testing and release for distribution
According to 21 CFR 211, which section pertains to the control of microbiological contamination?
211.113-Control on microbiological contamination
In 21 CFR 211, which section outlines the requirements for tamper-evident packaging for over-the-counter (OTC) drug products?
211.132-Tamper evident packing requirement for OTC Drug product
Which part of 21 CFR 211 addresses the requirements for holding and distribution procedures?
Subpart H- Holding & Distribution
What is the purpose of FDA Form 483?
To document inspectional observations
What is the purpose of CFR Title 21?
To set rules for food and drug administration
When does a recall of a product occur?
Whenever FDA raises concerns about the product
Test your knowledge of food and drug safety regulations with this quiz. Learn about proper labeling, regulatory programs, FDA standards, and inspection processes.
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