A Form 483 Inspectional Observations (commonly referred to as a 483) is issued only by the investigators/inspectors who performed the inspection, and only at the close of an inspection. It lists any objectionable observations, i.e., GMP deficiencies, noted during the inspection. If no GMP deficiencies were noted, no 483 is issued. This is a delightful outcome of an inspection, but is uncommon.
Responses to 483s are not required, but it would be foolish not to respond. The response provides the company's perspective and explanation of anything the investigators listed on the 483. Responses must be submitted to FDA within 15 days, not 30 days.
An Establishment Inspection Report (EIR) is written by the investigators/inspectors to document everything they saw and all discussions that occurred during the inspection. Usually these are completed within a month after the inspection, but not always. If a 483 was issued, the EIR will provide detailed discussions of the observations and will include documentation collected during the inspection that support the observations. These can become the basis for additional regulatory action, if required.
The EIR will report on the entire scope of the inspection. This can include a single product on a multi-product site, an entire site and all products manufactured there, several sites of a specified company, a particular building (e.g., a new warehouse or QC facility) or whatever the purpose of the inspection was. EIRs relate only to a single inspection, and have no relevance to other sites, facilities or products of the company if those were not covered during the inspection. It is simply a report that describes FDA's perspective on that particular inspection.
If no 483 was issued, an EIR must still be written by the inspectors/investigators to document the scope and findings of the inspection.
FDA does not issue GMP certificates. An EIR is simply a report describing what happened during a single inspection, and therefore has no 'expiration date' or period of validity. An EIR is not a GMP certificate, and has no similarity to a GMP certificate.
Regards,
Kirsten
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Kirsten L. Vadheim PhD, RAC
Principal
BioCompliance Consulting, Inc.
Redmond WA
United States
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Original Message:
Sent: 11-25-2013 11:26
From: Shrivathsa Achar
Subject: EIR (Establishment Inspection Report) issued from FDA
Hi
FDA upon inspection of facility issues 483s if there are observations (normally this will be issued during the inspection or immediately after). Either after resolution of 483s or if there are no 483s CDER/CBER issues Establishment Inspection Report to the inspected entity.
Usually EIR will be site specific, where, if the 483s are addressed, FDA will classify the facility as acceptable. For many other countries, this serves as GMP certificate. There is no stipulated expiry, but normally this will be considered valid by regulators for three years.
Regards,
Shrivathsa
Original Message:
Sent: 11-24-2013 01:35
From: Sattu Sreenu Babu
Subject: EIR (Establishment Inspection Report) issued from FDA
Hi NaRi Jung,
Upon completion of FDA Inspection, if there are any deficiencies, then FDA will issue FDA Form 483 (Inspectional Observations) to the Manufacturer.
Then the FDA Investigator will send the report to the District Office. If US Domestic facility, the corresponding FDA District Office will send the EIR to the manufacturer; if Foreign Manufacturing Site, the Centre (CBER/CDRH,etc..) will send the EIR to the Manufacturer.
EIR will result into three actions:
- No Action Indicated (Site is in Compliance) (NAI)
- Voluntary Action Indicated (VAI)
- Official ACtion Indicated (OAI)
If the manufacturers receive the FDA Form 483, then they will send the 483 response to FDA within 30 days.
If FDA is not satisfied with the response, then it may issue a Warning Letter to the Manufacturers.
EIR is not equivalent to a GMP Certificate; it's a report only, not certificate, with no expiration date.
Regards,
Sreenu
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Sattu Sreenu Babu
Manager-Regulatory Affairs - SEA Region
Life Technologies
Singapore
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Original Message:
Sent: 11-23-2013 03:26
From: NaRi Jung
Subject: EIR (Establishment Inspection Report) issued from FDA
I am wondering whether EIR has same effect with GMP certificate.
As far as I know, EIR is a kind of inspection report which issed by inspector to inform deficiencies in facility to manufacturer. Unless manufacturer correct the deficiencies, I guess EIR cannot be used as GMP certificate.
Furthermore, does EIR has a kind of expiry date?
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NaRi Jung
RA country manager
Korea, Republic of
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