USFDA Audit in Pharmaceutical industry l Interview Question and answers l USFDA inspection Form 483

USFDA Audit in Pharmaceutical industry l Interview Question and answers l USFDA inspection Form 483
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Questions covered:
Q. Why USFDA audit is important in pharmaceutical industry ?
Q. What is frequency of USFDA audit in pharmaceutical industry ?
Q. Which documents are commonly needed during USFDA audit ?
Q. In Which countries USFDA has its offices ?
Q. What is form 482 , form 483, form 484 and EIR ?
Q. What is typical content of 483 form ?
Q. Whether Form 483 and warning letter are same ?
Q. What are the key steps for USFDA approval for facility ?
Q. Which sectors come under the purview of USFDA ?
Q. When should a pharmaceutical company respond to a Form 483 issued by the USFDA ?
Q. What are some common areas or processes within a pharmaceutical facility that are typically scrutinized during a USFDA audit?
Q. What are the four types of FDA inspections ?
Q. What is basic purpose of USFDA inspections ?
Q. What is USFDA inspection outcomes are classified ?
Q. Compliance with which USFDA guidelines is checked during USFDA inspection ?
Q. What are some examples of Good Manufacturing Practices (GMP) violations that could result in a Form 483 being issued by the USFDA?
Q. What are the potential consequences for a pharmaceutical company if it fails to address the observations outlined in a Form 483 issued by the USFDA?
Q. What are the important Do’s and Don'ts during USFDA audit ?
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