Establishment Inspection Report preparation

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). 

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. 

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... 

After report preparation and establishing a proposed classification, the EIR is sent to FDA headquarters with all its attachments and exhibits. The centers GLP pharmacologists evaluate the EIR and make the final classification of the inspections assigned by that center. 

A report of each regulatory inspection should be prepared by the inspector (or inspectors) who performed the inspection. The report should be reviewed and approved according to established internal procedures. The scope, layout, content, timing and distribution of inspection reports may vary according to the ... 

These standards originally concerned animal safety studies today, they are applied to all animal studies, for example, toxicology, pharmacology and animal PK. GLP was legalized as an MHLW Ordinance in 21 March 1997, requiring in particular to establish SOPs and the preparation of protocols and study reports. PMDA is conducting GLP compliance reviews and on-site inspections of testing facilities. 

The report to be prepared after each inspection shall only contain facts relevant to compliance with this Convention. The report shall be handled in accordance with the regulations established by the Organization governing the handling of confidential information. If necessary, the information contained in the report shall be processed into less sensitive forms before it is transmitted outside the Technical Secretariat and the inspected State Party. 

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