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Questions and Answers
What type of facilities does the FDA inspect to ensure compliance with regulations?
What type of facilities does the FDA inspect to ensure compliance with regulations?
- Vaccine and drug manufacturers only
- Blood banks and food processing facilities only
- Various types including blood banks, food processing facilities, and clinical trial laboratories (correct)
- Dairy farms, animal feed processors, and clinical trial laboratories only
In what situations would the FDA conduct a for-cause inspection?
In what situations would the FDA conduct a for-cause inspection?
- To verify compliance with routine inspections
- To conduct pre-approval inspections for new products
- To inspect foreign manufacturing and processing sites
- To investigate a specific problem brought to the FDA's attention (correct)
What type of records of inspections does the FDA make available to the public?
What type of records of inspections does the FDA make available to the public?
- Certain frequently requested records in an electronic reading room (correct)
- All inspection records in physical reading rooms
- Pre-approval inspection records in an electronic reading room
- Only routine inspection records in an electronic reading room
Which section of 21 CFR 211 deals with the testing and release for distribution of drug products?
Which section of 21 CFR 211 deals with the testing and release for distribution of drug products?
According to 21 CFR 211, which section pertains to the control of microbiological contamination?
According to 21 CFR 211, which section pertains to the control of microbiological contamination?
In 21 CFR 211, which section outlines the requirements for tamper-evident packaging for over-the-counter (OTC) drug products?
In 21 CFR 211, which section outlines the requirements for tamper-evident packaging for over-the-counter (OTC) drug products?
Which part of 21 CFR 211 addresses the requirements for holding and distribution procedures?
Which part of 21 CFR 211 addresses the requirements for holding and distribution procedures?
What is the purpose of FDA Form 483?
What is the purpose of FDA Form 483?
What is the purpose of CFR Title 21?
What is the purpose of CFR Title 21?
When does a recall of a product occur?
When does a recall of a product occur?
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Study Notes
FDA Inspections
- The FDA inspects a variety of facilities including pharmaceutical manufacturers, medical device manufacturers, food processing plants, and research labs.
- Inspections ensure compliance with regulations to protect public health and safety.
For-Cause Inspections
- For-cause inspections are conducted in response to specific concerns such as product recalls, reports of adverse events, or quality control issues.
- These inspections address immediate risks that may affect consumer safety or product quality.
Public Inspection Records
- The FDA makes certain inspection records available to the public, including establishment inspection reports and 483 forms issued during inspections.
- These records enhance transparency and allow stakeholders to review compliance history.
21 CFR 211 – Drug Testing and Release
- Section 211.165 of 21 CFR outlines requirements for testing and release for distribution of drug products.
- This section ensures products meet quality standards before being made available to consumers.
Microbiological Contamination Control
- Section 211.113 of 21 CFR addresses the control of microbiological contamination in drug products.
- Proper controls are essential for ensuring product safety and preventing contamination-related health risks.
Tamper-Evident Packaging for OTC Drugs
- Section 211.132 of 21 CFR requires tamper-evident packaging for over-the-counter drug products.
- This regulation is aimed at enhancing consumer safety by minimizing risks of tampering.
Holding and Distribution Procedures
- Section 211.142 of 21 CFR sets forth requirements related to holding and distribution of drug products.
- Proper procedures ensure that products are stored and distributed under appropriate conditions to maintain their quality.
Purpose of FDA Form 483
- FDA Form 483 is issued when an inspection officials observe conditions that may violate FDA regulations.
- It serves as a written communication of observed deficiencies and prompts necessary corrective actions from the companies involved.
Purpose of CFR Title 21
- CFR Title 21 establishes regulations for food and drugs to ensure safety, efficacy, and quality.
- It governs practices in food and drug manufacturing, labeling, and marketing.
Product Recall Occurrence
- A recall occurs when there is a violation of law associated with a product that poses a risk to health.
- Reasons include adverse health effects, product contamination, or mislabeling.
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