Questions and Answers
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?
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According to 21 CFR 211, which section pertains to the control of microbiological contamination?
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In 21 CFR 211, which section outlines the requirements for tamper-evident packaging for over-the-counter (OTC) drug products?
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Which part of 21 CFR 211 addresses the requirements for holding and distribution procedures?
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What is the purpose of FDA Form 483?
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What is the purpose of CFR Title 21?
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When does a recall of a product occur?
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