FDA FMD-145 Establishment Inspection Report (EIR) Apostille
- USnotary
- 3 days ago
- 3 min read
Updated: 2 days ago
What is an FMD-145 and EIR (Establishment Inspection Report)?
✅ What is FMD-145
FMD-145 stands for “Field Management Directive 145.” It is a formal FDA policy/procedure document.
This directive governs how and when the FDA provides a copy of the EIR to a facility (or establishment) that was inspected.
Under FMD-145, when an inspection (domestic or foreign) by FDA (or by an FDA-contracted authority) is “closed” under the relevant regulation (21 C.F.R. § 20.64(d)(3)), the inspected establishment becomes eligible to receive one copy of the EIR.
The copy is addressed to the firm’s top management (or their designee).
✅ What is an Establishment Inspection Report (EIR)
An EIR is the detailed report produced by the FDA (or contracted authority) following an inspection of a facility (manufacturing plant, lab, etc.). It summarizes the findings, observations, and any compliance issues discovered during the inspection.
For medical device and other regulated firms, after inspection the investigators prepare the EIR; it is reviewed, endorsed, and classified internally by FDA.
The EIR typically follows or complements the preliminary observations often noted on a separate form known as Form FDA 483, which documents inspectional observations.
🎯 What does “FMD-145 EIR” refer to
When people say “FMD-145 EIR,” they generally refer to the release of the EIR to the inspected establishment under the rules of FMD-145. In other words:
The EIR was prepared following an FDA inspection.
The inspection is closed/complete in a way that qualifies under FMD-145.
Under FMD-145 the firm is receiving (or is eligible to receive) a copy of the report.
Receiving the “FMD-145 EIR” indicates that the inspection concluded and that, at least at the time of release, FDA did not intend immediate additional enforcement action (for example in cases classified as “No Action Indicated” or “Voluntary Action Indicated”).
🔎 What does an EIR look like? 👇
How to Apostille or Authenticate a Establishment Inspection Report (EIR) ?
Document issued by the Department of Health and Human Services FDA division in the United States needs to be apostilled or authenticated before its use in other countries outside the United States.
Requirements for your FDA Establishment Inspection Report (EIR) Certificate
Must be original
Must be on agency letterhead
Must include a legible signature of the official's name, printed name and title, and seal of the agency
The apostille or authentication process for you is quite simple. Simply place an order below according to your situation and email us the original document which needs apostille or authentication.
1. Order the Apostille service online.
▶️ If the destination country is a member of the Hague Convention of 1961, it needs to get an Apostille certificate. Once the apostille is completed, It is ready for use.
▶️ However, if the destination country is NOT a member of the Hague Convention of 1961, more steps are needed. Specifically, the document needs to be authenticated by the U.S. Department of State, and the embassy of that destination country which is located in Washington D.C.
2. After you place the order, please email the original digital copy of the EIR to info@usnotarycenter.com.
That's it. Once the apostille or authentication process is completed, we will mail it to your mailing address, either domestically or internationally. Shipping costs apply.
We provide apostille, authentication, and embassy legalization services for other personal documents and corporate documents issued in 50 states and DC.
If you have any questions and do not know which service to order, please contact us by describing ① the type of the document, ② which state the doc is from, and ③ in which country the doc will be used, and we will get back to you as soon as possible.
American Notary Service Center Inc. provides fair, fast, confidential, and professional document notarization and certification services for our clients. We also provide various assistance services to small businesses led by socially and economically disadvantaged groups. Our service helps small businesses obtain federal government contracts, gain a foothold in the market, and boost their sales. For more information, please visit our website at www.usnotarycenter.com, and contact us by calling 202-599-0777 or by email at info@usnotarycenter.com.