Establishment Inspection Report

If the test facility claims to be GLP-compliant but is located in a country where there is no authorised body responsible for GLP monitoring, i.e., a national GLP compliance program, the Study Director needs to be assured that the facility (including the archive, if used) does operate in compliance with GLP principles. This can be achieved by conducting a pre-study QA test site inspection or by a review of documentary evidence, e.g., notice of adverse findings and subsequent responses, or Establishment Inspection reports. The Study Director should ideally discuss the above with QA personnel and send copies of any documentary evidence used to the Quality Assurance Unit (QAU) for inclusion in the QA multi-site study file. 

After inspection, the inspector prepares a detailed Establishment Inspection Report (EIR). This is the FDA s primary record for the inspection. Time is given to the manufacturer to respond to the deficiencies found and recorded on Form FDA-483. Failure to comply with satisfactory resolution of the deficiencies found will result in the FDA sending out a Warning Letter notifying the manufacturer to comply. If the manufacturer is unable to resolve the deficiency after the deadline set by the FDA, the FDA may proceed to prosecute the manufacturer with an injunction. The injunction is a court order called Consent Decree, and the manufacturer may be required to cease operations until the problem is rectified (see Exhibit 10.4). 

Establishment Inspection Report Establishment License Application enzyme linked immunosorbent assay European Medicines Agency Environmental Protection Agency European Public Assessment Report end of production cell bank erythropoietin... 

The Team Biologics report is known as an Establishment Inspection Report, which consists of a list of observations recorded on a Form 483. In the Findings section, both products and processes are discussed and various processes are rated. Inspections of both products and the establishment focus on systematic evaluation of quality. Inspection Reports may recommend warning letters, notice of intent to revoke licenses, or civil or criminal legal action. 

In addition to providing a form FDA-483, FDA investigators prepare an establishment inspection report (EIR), which is sent to FDA headquarters, which then evaluates the report and determines the corrective action, if any. The FDA then classifies the inspection as no action indicated, voluntary action indicated, or official action indicated. The EIR contains much greater detail than contained in the 483 and is not provided to the manufacturer until after the inspection is deemed closed. 

Establishment inspection reports are generated by FDA investigators after performing an inspection and delineate all the investigator s findings, observations, and perspectives, as well as FD-483 observations. 

Another general distinction between FDA and EU inspections relates to the disclosure of certain information obtained during an inspection. In the United States, anyone can submit a written request to FDA, pursuant to the Freedom of Information Act (FOIA), to obtain a copy of an FD-483 issued to a company (i.e., a listing of observations by an FDA investigator of a facility s potential noncompliance), the company s response, the establishment inspection report (i.e., the investigator s diary of the inspection), and any resulting enforcement action, such as the issuance of a warning letter. 

EU GLP compliance certificate or US inspection history with most recent Establishment Inspection Report. 

After inspection, the inspector prepares a detailed Establishment Inspection Report (EIR). This is the FDA s primary record for the inspection. Time is given to manufacturer to respond to the deficiencies found and... 

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