At the end of an inspection, the FDA investigator conducts an exit interview with the clinical investigator or his/her representative. At this interview, the FDA investigator who conducted the inspection reviews and discusses the findings from the inspection and, if deficiencies were found, issues a written Form FDA 483 (Inspectional Observations; 483) to the clinical investigator or his/her representative. The 483 describes any inspectional observations that, in the opinion of the FDA investigator conducting the inspection, represent deviations from applicable statutes and regulations.
Some common deficiencies that have been observed by FDA investigators during a clinical investigator inspection include:
failure to follow the investigational plan and signed investigator statement/agreement (e.g., failure to conduct or supervise the study in accordance with the relevant, current protocol(s)). See 21 CFR 312.60 and 812.110(b).
• protocol deviations (e.g., failure to appropriately document and report any medically necessary protocol deviations). See 21 CFR 312.66 and 812.150(a)(4).
• inadequate recordkeeping. See 21 CFR 312.62 and 812.140(a).
• inadequate accountability for the investigational product. See 21 CFR 312.62(a) and 812.140(a)(2).
• inadequate subject protection, including informed consent issues. See 21 CFR part 50, 312.60, and 812.100.
The clinical investigator may respond to the 483 observations orally during the exit interview and/or respond in writing after the inspection. If the clinical investigator chooses to respond in writing to the deficiencies listed on the 483, the response should be directed to the FDA District Office listed in the upper left corner of the 483.
Following the inspection, the FDA investigator who conducted the inspection prepares a written Establishment Inspection Report (EIR). The EIR, Form FDA 483 (if issued), copies of any materials collected during the inspection, and any clinical investigator response that has been received by the District Office are forwarded to the appropriate FDA Center for further evaluation and final classification of the inspection outcome. After this review, one of the following types of letters is typically sent from the appropriate FDA Center to the clinical investigator:
(1) A letter that generally states that FDA observed basic compliance with pertinent regulations. Note that a letter is not always sent when FDA observes no significant deviations.
(2) An Informational or Untitled Letter that identifies deviations from statutes and regulations that do not meet the threshold of regulatory significance for a Warning Letter. Generally, such letters may request a written response from the clinical investigator.
(3) A Warning Letter that identifies serious deviations from applicable statutes and regulations.
(4) A Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE). FDA may initiate a process to disqualify the clinical investigator from receiving investigational new drugs and/or biologics if disqualified under part 312, or investigational devices if disqualified under part 812, if the investigator has repeatedly or deliberately failed to comply with applicable regulatory requirements or has deliberately or repeatedly submitted false information to the sponsor or FDA in any required report. See 21 CFR 312.70 and 812.119. The NIDPOE identifies alleged violations and provides the investigator with an opportunity to explain the matter at an informal conference or in writing. If, in response to the NIDPOE, the investigator provides an explanation that is accepted by the agency and the disqualification is not warranted, alternatives such as a detailed corrective action plan may be considered. If the investigator’s explanation is not accepted by the agency, the FDA may issue a Notice of Opportunity for Hearing (NOOH) under 21 CFR part 16.
Requiremets US FDA Inspections of Clinical Investigators of Clinical Trials
PROCEDURE OF AN INSPECTIONS OF CLINICAL TRIAL INVESTIGATOR BY US FDA ,HOW ARE CLINICAL INVESTIGATOR INSPECTIONS CONDUCTED?
US FDA INSPECTION OF CLINICAL INVESTIGATORS OUT OF UNITED STATES OF AMERICA
Do you know now this website has become a most popular and most referred website in pharmaceutical industry and pharmaceutical companies and pharmaceutical manufacturers from all over the world ,for almost all topics related to Pharmaceutical Manufacturing , Pharmaceutical Regulatory Affairs and Good Manufacturing Practice for Pharmaceutical Manufacturing (c GMP guidelines ) and latest news and new drugs developments.
You may also like following articles
What is Generic Drug
What is Referance Listed Drug ? ( RLD )
What is Pharmaceutical Equivalents
What is Pharmaceutical Alternatives
What is Therapeutic Equivalents
Why a drug is bound to protein, What is protein binding? What is drug absorption , distribution ?
Do Physical properties contribute to drug activity.
What is drug receptor , How a drug resistance occurs
Drug interaction, and its examples
What is first pass metabolism of a drug
What is What is 510(k) Clearances ?
Premarket Notification for medical devices – PMN or 510(k)
Antibiotic Definition and classification
Antibiotic resitance and Antibiotic resistance mechanism
Vitamin D Details on FDA cautions on accurate dosage of Vitamin D
What is an antibody? what is monoclonal and polyclonal antibodies?
Terminologies In vaccine Production
Multi stage testing of Virus vaccine production
Testing of vaccines at different stages of production
TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION
Enzyme linked immunosorbent assay ELISA
Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.
Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in
Types of validations in pharmaceutical manufacturing
Requirements of documents for validation of sterilisation process
How to investigate OOS out of specification results
Determination of Phenol coefficient of a disinfectant
Time limitations in sterile pharmaceuticals processing
Aspects of validation of manufacturing process in sterile pharmaceuticals
Controlling Pyrogens in injectable dosage forms
Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation
New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA
Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA
How to make Investigational New Drug (IND) Application to US FDA
Drug applications submission to us fda Over the counter Drugs OTC drugs
BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Electronic record in pharmaceutical manufacturing industry
Good manufacturing practice in pharmaceutical industry
Pharmaceutical industry pharmaceutical companies and FDA latest updates
Here is an interesting article on world wide pharmaceutical industry and making a carrier in one of pharmaceutical companies article on Pharmaceutical Industry pharmaceutical industry
Find a Job in Pharmaceutical Company –>JOBS IN PHARMA INDUSTRY<—
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies
Here are some interesting articles on Quality assurance systems for pharmaceutical company
1.Quality assurance in pharma industry
2.Quality by designe concept for pharmaceutical industry
3.Quality by designe concept in pharmaceutical industryan explanation