How to Request an Establishment Inspection Report (EIR)

Understanding the Relationship Between FOIA and EIR Requests

An Establishment Inspection Report (EIR) is a federal record maintained by the U.S. Food and Drug Administration (FDA) and can be requested under the Freedom of Information Act (FOIA), which was enacted in 1966 and became effective on July 4, 1967. FOIA is a federal law that guarantees citizens’ right to access information held by federal government agencies, promoting transparency and accountability in government operations.

The EIR documents the findings of FDA inspections conducted at regulated facilities, including pharmaceutical manufacturing sites, medical device manufacturers, food processing facilities, and other establishments under FDA’s jurisdiction. While EIRs are generally accessible to the public through FOIA requests, certain information may be redacted before disclosure to protect trade secrets, confidential commercial information, personal privacy, and other exempted categories under FOIA.

Step-by-Step Guide to Requesting an EIR

Step 1: Prepare Your FOIA Request

Before submitting your request, it is advisable to gather and organize the following information to ensure an efficient and accurate search by FDA:

• The exact name and complete address of the inspected facility
• The specific dates or date range when the inspection was conducted
• Information about the FDA District Office that conducted the inspection (if known)
• Details about specific products or manufacturing lines related to the inspection (if applicable)
• The FDA Establishment Identifier (FEI) number, if available (this unique identifier can significantly expedite the search process)

Having comprehensive and accurate information helps FDA staff locate the requested records more quickly and reduces the likelihood of delays or additional clarification requests.

Step 2: Methods for Submitting Your FOIA Request to FDA

The FDA accepts FOIA requests through multiple channels. Each method is equally valid, though some offer advantages in terms of convenience and tracking capabilities.

Method A: Online Form Submission (Recommended)

Using FDA’s FOIA Electronic Reading Room and online request portal is the most efficient method. The online system can be accessed at: https://www.fda.gov/regulatory-information/freedom-information/how-make-foia-request

The online portal allows you to complete all required fields, attach supporting documentation if needed, receive automatic confirmation, and track the status of your request in real-time. This method typically results in faster processing and easier communication regarding your request.

Method B: Email Submission

You may submit your FOIA request via email to FDA’s FOIA office at: FOIA@fda.hhs.gov

When using email, clearly indicate “FOIA Request for EIR” in the subject line and include all required information in the body of the email or in an attached document. You should receive an acknowledgment email with a tracking number within approximately 10 business days.

Method C: Mail Submission

Written requests can be sent to the following address:

Division of Freedom of Information
Office of the Executive Secretariat, OC
U.S. Food and Drug Administration
5630 Fishers Lane, Room 1035
Rockville, MD 20857

When submitting by mail, consider using certified mail with return receipt to confirm delivery and maintain a record of your submission date.

Method D: Fax Submission

Fax submissions are accepted at: 301-827-9267

As with other methods, ensure that your fax clearly identifies itself as a FOIA request and includes all necessary information.

Step 3: Essential Information to Include in Your Request

Regardless of the submission method chosen, your FOIA request must contain the following elements to be properly processed:

Required Statement: Begin with the phrase “This is a request under the Freedom of Information Act” to clearly identify the legal basis for your request.

Detailed Description of Records: Provide a specific and detailed description of the documents you are seeking. For example: “Establishment Inspection Report for [Company Name] facility located at [Complete Address], inspected during the period of [Start Date] to [End Date].” Include the FEI number if known.

Requester Information: Provide your full name, organizational affiliation (if applicable), complete mailing address, telephone number, and email address. This information is necessary for FDA to communicate with you regarding your request and to send you the responsive records.

Fee Information: Specify the maximum amount you are willing to pay for search, review, and duplication fees. You may state “I am willing to pay fees up to $[amount]” or request notification if fees will exceed a certain amount before FDA processes the request.

Fee Category and Waiver Request: If applicable, identify your fee category (commercial requester, educational institution, news media, or other) and request a fee waiver or reduction if you qualify based on public interest grounds.

Preferred Format: Indicate your preferred format for receiving records, such as electronic delivery via email (PDF format) or paper copies. Electronic delivery is generally faster and often less expensive.

Expedited Processing Request: If circumstances warrant expedited processing (such as urgent need related to imminent danger to life or safety, or for news media covering breaking news), you may request expedited processing and provide justification.

Step 4: Understanding FOIA Fees

FOIA requests may incur fees depending on the category of requester and the nature of the request. FDA’s fee structure includes:

Search Fees: Costs associated with the time spent by FDA personnel locating and retrieving requested records. The first two hours of search time are provided without charge for all requesters except commercial requesters.

Review Fees: Costs for examining records to determine whether any portion is exempt from disclosure. Review fees apply only to commercial requesters and only for the initial review (not for administrative appeals).

Duplication Fees: Charges for copying records, whether in paper or electronic format. The first 100 pages of paper copies are provided without charge for non-commercial requesters.

Fee Categories: Different fee structures apply based on requester category. Non-profit educational institutions, non-commercial scientific institutions, and news media representatives typically qualify for reduced fees or fee waivers. Individual requesters seeking information for personal use may also qualify for reduced fees.

Fee Waivers: Fees may be waived or reduced if disclosure of the information is in the public interest because it is likely to contribute significantly to public understanding of government operations or activities, and the request is not primarily in the commercial interest of the requester.

The FOIA Request Process Timeline and Response

Step 1: Acknowledgment of Receipt

Upon receiving your FOIA request, FDA will typically send an acknowledgment within 10 business days. This acknowledgment will include a unique tracking number assigned to your request, which you should retain for all future inquiries and correspondence regarding your request. The tracking number allows both you and FDA to efficiently reference your specific request.

Step 2: Processing and Response Timeline

Under FOIA regulations, federal agencies are required to respond to requests within 20 business days from receipt. However, this timeframe represents the deadline for an initial determination, not necessarily the delivery of documents. The actual time required to fulfill a request can vary significantly based on several factors:

Simple Requests: Straightforward requests for a single, recent EIR may be processed within the statutory 20-day period or shortly thereafter.

Complex Requests: Requests involving multiple facilities, extensive date ranges, voluminous records, or requiring consultation with other offices or agencies may take several months to process. FDA may invoke a 10-business-day extension for “unusual circumstances” such as the need to search multiple locations, review voluminous records, or consult with other agencies.

Multitrack Processing: FDA employs a multitrack processing system that categorizes requests based on complexity. Simple requests are processed more quickly, while complex requests requiring extensive review are placed in a separate track with longer processing times.

Tracking Your Request: You can monitor the status of your request through FDA’s online FOIA portal if you submitted electronically, or by contacting FDA’s FOIA office at 301-796-3900, referencing your tracking number.

Step 3: Evaluating FDA’s Response

FDA’s response to your FOIA request will take one of several forms:

Full Grant: All requested records are provided in their entirety without redactions. This indicates that no exemptions apply to the information you requested.

Partial Grant/Partial Denial: Some portions of the requested records are provided, while other portions are withheld under one or more FOIA exemptions. Redacted information will be marked with exemption codes explaining the legal basis for withholding (such as Exemption 4 for trade secrets or Exemption 6 for personal privacy).

Full Denial: All requested records are withheld. The response will cite the specific FOIA exemption(s) justifying the denial.

No Records: FDA has conducted a reasonable search but found no records responsive to your request. This may occur if the inspection records have been destroyed according to the agency’s retention schedule, if the facility or dates are incorrectly identified, or if no inspection occurred during the specified timeframe.

Administrative Closure: Your request may be administratively closed if you fail to respond to FDA’s request for clarification, fee information, or other necessary information within the specified timeframe.

If you disagree with FDA’s decision to withhold information, redact portions of records, or deny your request entirely, you have the right to file an administrative appeal within 90 calendar days of the date of FDA’s response. Appeal instructions are provided in FDA’s response letter. If your appeal is denied, you may have the option to seek judicial review in federal court.

Best Practices for Efficient EIR Acquisition

Be Specific and Precise: The more specific and detailed your request, the easier it will be for FDA staff to locate the exact records you need. Include facility names exactly as they appear in FDA registration, complete addresses including suite or building numbers, precise inspection dates, and FEI numbers when available. Vague or overly broad requests may result in delays while FDA seeks clarification or may lead to the agency retrieving more records than you actually need, potentially increasing fees.

Narrow Your Scope When Appropriate: If you are only interested in specific sections of an EIR, such as observations related to a particular manufacturing line or quality system element, consider specifying that focus in your request. For example, you might request “portions of the EIR related to data integrity findings” rather than the complete report. However, be aware that overly narrow requests may result in missing relevant information if FDA interprets your scope differently than intended.

Request Electronic Format: Specify that you prefer to receive records in electronic format (typically PDF) rather than paper copies. Electronic delivery is generally faster, less expensive, and more convenient. PDF files can be easily searched, shared with colleagues, and stored without physical space requirements. Most EIRs are now maintained electronically by FDA, making electronic delivery the most efficient option.

Consider Consulting FDA’s Warning Letters Database: Before submitting a FOIA request for an EIR, check FDA’s publicly available Warning Letters database (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters). If a warning letter was issued following an inspection, it often summarizes key inspection observations and may provide sufficient information for your needs without requiring a FOIA request. The Form FDA 483 (Inspectional Observations) is also sometimes publicly available and can be obtained more quickly than a full EIR.

Proactively Monitor Request Status: If you have not received a response within the expected timeframe, proactively contact FDA’s FOIA office to check on your request’s status. Systematic follow-up every few weeks can help identify and resolve processing delays, misrouted requests, or other issues that might otherwise significantly extend response times.

Maintain Professional Communication: Throughout the FOIA process, maintain courteous and professional communication with FDA staff. FOIA officers handle numerous requests and operate under significant time pressures. Clear, respectful communication can facilitate more efficient processing of your request and better outcomes if issues arise.

Recent Developments and Considerations

Transition to Electronic Records: FDA has increasingly digitized its inspection processes and records management systems. The agency’s move toward electronic records has generally improved FOIA processing times for recent EIRs, though older records maintained in paper format may still require more time to locate and process.

COVID-19 Impact: The COVID-19 pandemic affected FDA’s inspection activities and FOIA operations. While inspection activities have largely resumed normal operations, some backlogs in FOIA processing may persist. Be prepared for potentially longer processing times than historical averages.

Confidential Information Protection: FDA has become increasingly vigilant about protecting confidential commercial information and trade secrets in response to industry concerns and legal developments. You may encounter more extensive redactions in recent EIRs compared to older records, particularly regarding manufacturing processes, formulations, and proprietary quality control methods.

Relationship to FDA’s Transparency Initiatives: FDA has committed to enhanced transparency regarding inspection activities. While EIRs remain accessible primarily through FOIA, the agency has expanded public access to Form FDA 483s and related inspection information through its website. These transparency initiatives complement, but do not replace, the FOIA process for obtaining complete EIRs.

Conclusion

The Establishment Inspection Report serves as a critical information resource for understanding FDA’s inspection findings, supporting regulatory compliance efforts, benchmarking quality system performance, and informing risk management strategies. While the FOIA request process may initially appear complex, following the systematic approach outlined in this guide will enable you to efficiently obtain the information you need.

By submitting well-crafted requests with specific, accurate information, choosing appropriate submission methods, understanding the applicable fee structure, and monitoring your request’s progress, you can successfully navigate the FOIA process. The insights gained from EIRs can significantly enhance your organization’s compliance posture, help identify industry trends and common deficiencies, and support continuous improvement of quality systems.

As regulatory expectations continue to evolve and FDA’s inspection approaches adapt to new technologies and challenges, maintaining awareness of inspection findings through EIRs and other publicly available FDA documents remains an essential component of effective pharmaceutical quality management and regulatory intelligence.

Useful References and Resources

FDA FOIA Resources:

• FDA Freedom of Information: https://www.fda.gov/regulatory-information/freedom-information
• How to Make a FOIA Request: https://www.fda.gov/regulatory-information/freedom-information/how-make-foia-request
• FOIA Electronic Reading Room: https://www.fda.gov/regulatory-information/freedom-information/electronic-reading-room

FDA Inspection Resources:

• Inspections, Compliance, Enforcement, and Criminal Investigations: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations
• Investigations Operations Manual (IOM): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual
• Warning Letters: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters

Legal Resources:

• FOIA Statute (5 U.S.C. § 552): https://www.govinfo.gov/content/pkg/USCODE-2018-title5/pdf/USCODE-2018-title5-partI-chap5-subchapII-sec552.pdf
• Department of Justice FOIA Guide: https://www.justice.gov/oip/doj-guide-freedom-information-act-0