Is it in Your EIR
The V in JIVR stands for this
What is Violation
WHAT CHAPTER TALKS ABOUT INSPECTIONS
WHAT IS CHAPTER 5
What type of manufacturer does the 210 and 211's do not apply to?
What is a API manufacturer
What violation do you have when an approved drug labeling has extra label uses
WHAT IS AN UNAPPROVED NEW DRUG
What section of the EIR describes roles, authorities and responsibilities of officials who provided you information is entitled this
What is Individual Responsibility
WHAT DOES IOM STAND FOR
What is INVESTIGATIONS OPERATIONS MANUAL
What do you do when a drug product does not match or meet the OTC monograph
What is include a description of the deviation in your EIR and discuss with the firm at inspection closure
WHAT DOES GRASE
WHAT IS GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE
What section of the EIR describes improvements initiated by the firm in response to a previous inspection, where they had observation cited and/or Warning Letter issued
What is Voluntary Corrections
What Chapter of the IOM talks about samples
What is Chapter 4
What typically determines the regulatory significance of the issues observed and the regulatory compliance status of the firm.
What is the potential impact on the product quality and public safety.
WHAT IS THE CITATION FOR THE INTRODUCTION INTO IS
WHAT IS 301
If evidence of interstate documentation is not available, what may be collected?
What is an affidavit with all other available records (Packing slips, invoices, certificates, receipt/prescription/distribution logs, statements from responsible individuals)
What is Chapter 2 of the IOM
What is Regulatory
This failure to do is not a reportable observation on a Form FDA-483.
What is a lack of Drug Registration or listing
A DRUG THAT IS NOT PROPERLY LABELED AND MARKETED IS CONSIDERED
WHAT IS MISBRANDED
The “So What?” factor pertains to what kind of approach when considering how a violation/observation impacts patient/consumer
What is Risk Based Approach
WHO DOES THE IOM INSTRUCT YOU TO ISSUE THE 482 TO
WHAT IS THE MOST RESPONSIBLE PERSON ONSITE
What should the firm submit if they get information regarding bacteriological contamination of the product within three working days of receipt of the information?
What is an NDA-Field Alert Report
CITATION FOR AN UNAPPROVED NEW DRUG
WHAT IS 505