🔄 Revised May 2, 2026
✍️ Dirk Adams
⌛ 7 min read
FAT RESEARCH SERIES — SEAFOOD
SEAFOOD RESEARCH SERIES | PAPER NO. 6
How the FDA Enforces Seafood Law
Warning Letters, Import Alerts, Product Sampling, and the Limits of the Public Record
Prepared for publication by Farm Animal Transparency | March 30, 2026
FDA’s seafood enforcement record is public and substantial, but it is fragmented across manuals, warning letters, import alerts, recalls, inspection databases, and FOIA reading-room records rather than collected in one complete file.1
At a glance
FDA’s seafood enforcement protocols are public. The Investigations Operations Manual, Regulatory Procedures Manual, and Food Compliance Program 7303.842 together describe how FDA investigators inspect seafood importers and processors, prioritize cases, document misbranding, and escalate to warning letters or detention without physical examination.1
For most FDA-regulated seafood, the key importer duty is Seafood HACCP “affirmative steps” under 21 C.F.R. § 123.12, not FSVP. FDA guidance says fish and fishery products imported from foreign suppliers that are subject to and in compliance with Part 123 are exempt from FSVP, and importers of those products instead must comply with the seafood HACCP importer requirements.2
Public seafood enforcement is visible mainly through warning letters, import alerts, recalls and advisories, inspection classifications, and some published Form 483 and FOIA records. FDA describes warning letters as its principal means of achieving prompt voluntary compliance, and import alerts allow detention without physical examination of future shipments.3
Recent public records show active seafood enforcement against importers, domestic processors, foreign processors, and contaminated imports. In 2025–2026, FDA issued seafood warning letters to a New York importer for failing to implement required affirmative steps, to an Iowa processor over live-oyster HACCP deficiencies, to a Hawaii processor after environmental swabs found Listeria monocytogenes, and to foreign seafood firms after both on-site and remote assessments. FDA also issued a public advisory and import-alert action involving Indonesian shrimp linked to cesium-137 concerns.4
The public record is real but incomplete, and GAO has repeatedly found structural weaknesses in the program. FDA says its inspection classification database is not comprehensive, its general recall page does not include every recall, its 483 spreadsheets are not comprehensive and omit manually prepared 483s, and its dashboard includes only selected finalized compliance actions. GAO found FDA averaged 917 foreign food-facility inspections a year from FY2018 through FY2023, and GAO’s review of seafood import-alert removals found no audit sampling before 260 of 274 removal decisions and no follow-up inspection before removal for 31 of 32 firms with relevant OAI findings.5
Executive Summary
FDA is the primary federal regulator for most seafood sold in the United States. FDA says it is responsible for ensuring that the nation’s seafood supply, domestic and imported, is safe, sanitary, wholesome, and honestly labeled, while catfish and other Siluriformes are primarily regulated by USDA. FDA’s imported-seafood program states that imported seafood is held to the same safety standards as domestic food, and FDA’s main seafood compliance program, CP 7303.842, covers both domestic and foreign firms that import or process fish and fishery products.6
The enforcement architecture is more administrative than judicial. FDA’s own compliance materials describe a spectrum that begins with inspections, sampling, and inspectional observations, moves to warning letters and import alerts, and can escalate to recalls, seizures, injunctions, and criminal prosecution. In seafood specifically, CP 7303.842 instructs FDA personnel that warning letters should be considered for significant seafood HACCP deviations, that foreign processors may be placed on detention without physical examination if deficiencies are not corrected, and that species misbranding is a regulatory violation that can support future import detention for foreign-origin product.7
The public record shows that seafood enforcement is not limited to classic contamination cases. FDA treats species substitution and other seafood-labeling deception as misbranding and economic fraud. The agency says seafood must be labeled with truthful, non-misleading acceptable market names; in its compliance program it instructs investigators to record misbranding evidence on FDA-483 observations and a species-substitution questionnaire; and in a wholesale-labeling project spanning 14 states, FDA said it focused DNA testing on high-risk species and would use the results to guide future sampling, enforcement, and education.8
The practical problem is that transparency and enforcement capacity do not fully match the breadth of FDA’s mandate. FDA publishes a substantial body of manuals, warning letters, import alerts, inspection data, recall data, and FOIA reading-room records. But FDA also says several of those public datasets are incomplete, and GAO has repeatedly found serious weaknesses in foreign inspection volume, in seafood import sampling, and in FDA’s administration of import-alert removals. The result is a system that is plainly active, but only partially visible and still constrained in key areas.1
The public enforcement framework
FDA’s seafood enforcement framework is relatively easy to map because the main operating documents are public. FDA states that the Investigations Operations Manual is the primary operational reference for investigators and is publicly posted so outside stakeholders can understand FDA operations. FDA likewise posts the Regulatory Procedures Manual, which explains internal procedures for domestic and import regulatory matters, and the Food Compliance Programs page, which says those programs are made public under FOIA even though they do not bind the public.1
For seafood, the central operating document is Food Compliance Program 7303.842. The program says it provides regulatory coverage of domestic and foreign firms that import or process fish and fishery products; it instructs field staff on inspection, sampling, and prioritization; and it states that FDA conducts inspections of seafood processors and seafood importers for compliance with the seafood HACCP regulation in 21 C.F.R. Part 123 and relevant CGMP provisions in 21 C.F.R. Part 117. The program also explicitly places misbranding and species substitution within the inspection framework.9
One detail in CP 7303.842 matters for wholesale distributors and warehouse operators. For purposes of the FDA Form 3501 used in the seafood program, a warehouse storing the listed product is considered to be “actively processing” that product, even though a manufacturer, repacker, or relabeler that is only holding product at the time of inspection is not treated the same way for that form. The same program puts importer follow-up inspections high on the priority list when an importer previously received an OAI classification based on affirmative-step deficiencies, was associated with illness or safety-related violative entries, or had already received a warning letter.9
An important legal nuance is that seafood import enforcement runs chiefly through the seafood HACCP rule rather than the general FSVP regime. FDA guidance states that fish and fishery products imported from foreign suppliers that are subject to and in compliance with Part 123 are exempt from FSVP, and that importers of those products instead must comply with the importer-verification requirements in 21 C.F.R. § 123.12. In many seafood cases, the key importer question is whether the importer took the required HACCP affirmative steps, not whether it maintained a separate FSVP program.2
How seafood enforcement works in practice
FDA’s own Human Foods Program compliance page describes the full enforcement menu in plain terms: FDA protects consumers from unsafe food through inspection, voluntary destruction, sampling, recall, seizure, injunction, and criminal prosecution. That page also describes warning letters as the agency’s principal means of achieving prompt voluntary compliance, while CP 7303.842 says warning letters should be considered for significant seafood HACCP deviations. This helps explain why many public seafood enforcement records appear as warning letters and import actions rather than court filings.3
Import alerts are the most consequential public enforcement tool on the import side. FDA explains that it can place a product on an import alert after finding a violation and then detain future shipments without physically examining each one, a process FDA calls detention without physical examination, or DWPE. FDA also explains that import alerts are public, searchable, and updated in real time, and that firms, products, or countries can appear on red, yellow, or green lists depending on their status. In seafood, CP 7303.842 states that foreign processors may be subjected to DWPE if deficiencies found during foreign inspections or records reviews are not corrected.10
Sampling and laboratory testing are also part of seafood enforcement, but federal auditors have repeatedly described them as limited. GAO found in 2011 that FDA tested about 0.1 percent of imported seafood for drug residues in fiscal year 2009. GAO later reported that in fiscal year 2015 FDA examined 2.2 percent of imported seafood entry lines for food-safety issues and tested 0.1 percent of about 1 million seafood entry lines for drugs of concern; from fiscal years 2010 through 2015, FDA refused admission to 1,726 seafood products for drug-related violations, with shrimp accounting for 54 percent of those refusals.11
Labeling and species fraud are not side issues; they are part of the enforcement program. FDA says seafood must be labeled truthfully and with acceptable market names, and that false use of an acceptable market name can render a product misbranded. FDA’s economic-fraud page gives classic seafood examples such as selling a cheaper species as red snapper or representing imported crabmeat as blue crabmeat or farm-raised salmon as wild-caught salmon. CP 7303.842 goes further: it instructs investigators to record evidence of misbranding on Form FDA-483 and the species-substitution questionnaire, states that species misbranding is a violation of section 403(b), and says species misbranding linked to foreign-origin products may justify DWPE for future shipments from the implicated supplier.8
What recent public records show
Recent warning letters show active importer enforcement. In a January 2026 letter to Feng Foods Trading, FDA said it found serious seafood HACCP importer violations and specifically alleged that the firm had not implemented an affirmative step to ensure imported fish and fishery products were processed in compliance with the seafood HACCP regulation.12
Domestic processor letters show the same pattern on the manufacturing side. In February 2026, FDA wrote to Rio Verde Food Service in Iowa after inspectors found serious seafood HACCP violations at a seafood processing facility, including problems with critical limits in the firm’s live-oyster HACCP plan. In a December 2025 letter to Maui Seafood, FDA said environmental swabs taken in the company’s ready-to-eat seafood processing facility were positive for Listeria monocytogenes. Those records show how the seafood program combines HACCP review with environmental sampling and sanitation enforcement.13
Foreign processor enforcement is visible as well. FDA’s January 2025 warning letter to Yongdae Hwangtae Union Corp. in Korea said the firm had serious seafood HACCP violations and explicitly warned that noncompliance could lead to refusal of admission and placement on DWPE, citing Import Alert 16-120 as the seafood-HACCP alert for noncompliant foreign firms. FDA also issued seafood warning letters in 2025 following Foreign Remote Regulatory Assessments of facilities in Nicaragua and Venezuela, showing that public seafood enforcement includes remote foreign oversight as well as on-site foreign inspections.14
Public advisories and import actions also show FDA using non-warning-letter tools. In 2025, FDA advised the public not to eat, sell, or serve certain imported frozen shrimp from PT. Bahari Makmur Sejati in Indonesia, said CBP had alerted FDA to cesium-137 detections in shipping containers at four U.S. ports, and stated that the firm had been added to a new import alert for chemical contamination so that implicated shrimp would not enter U.S. commerce until the underlying conditions were resolved. That is a clear example of how surveillance, public warning, recall coordination, and import-alert authority can operate together.15
In the less common cases where administrative tools are not enough, seafood matters can escalate to court. FDA’s compliance page lists seizures and injunctions among its enforcement tools, and the seafood compliance program says potential seizures, injunctions, or prosecutions should be referred for evaluation. In 2022, DOJ announced that the United States had filed a complaint, at FDA’s request, to stop Felix Custom Smoking from distributing adulterated seafood products after inspectors documented filthy conditions and persistent Listeria monocytogenes contamination.16
The public record exists — but it is incomplete
A researcher can build a substantial seafood-enforcement archive from public FDA sources. FDA provides a searchable warning-letter database, a public import-alert system with real-time updates, the Inspection Classification Database, the FDA Data Dashboard, the OII FOIA Electronic Reading Room, public recall and enforcement-report pages, and annual spreadsheets summarizing system-generated Form FDA-483 observations. Taken together, these sources create a meaningful public record of seafood enforcement activity.17
But none of those sources is complete on its own, and several come with explicit caveats from FDA itself. FDA says the Inspection Classification Database is not a comprehensive listing of all inspections and should not be used as official counts. FDA says the general recalls page is built from press releases and other public notices and that not all recalls appear there, even though the weekly Enforcement Report lists recalls after classification. FDA says the 483 spreadsheets are not comprehensive and omit manually prepared 483s. And FDA says the Data Dashboard contains only selected data elements and only a subset of compliance actions, while foreign-firm actions often take the form of import alerts and are not included in that dashboard release.5
That is why FOIA still matters. FDA’s OII Electronic Reading Room says it posts select foreign and domestic inspection records proactively or because they are frequently requested, may redact nonpublic information, and directs requesters to submit a FOIA request for other inspection-related records not listed there. In practice, any serious seafood-enforcement study that aims to measure patterns over time will likely need both the public databases and targeted FOIA requests.18
Assessment
The public record supports two conclusions at the same time. First, FDA’s seafood enforcement program is genuine and ongoing. The agency has a public inspection manual, a public regulatory-procedures manual, a public seafood compliance program, a public warning-letter database, public import alerts, public recalls and advisories, and current examples of importer, processor, foreign-facility, contamination, and labeling enforcement. FDA’s 2026 priority deliverables also indicate a harder edge ahead: expanded import screening using AI and machine learning, continued shrimp sampling, development of a seafood-fraud identification program, and a push for authority to require destruction of imported seafood that poses a significant public-health risk. FDA also announced in 2025 that it would expand the use of unannounced inspections at foreign manufacturing facilities, including food facilities.19
Second, the same public record shows a program whose reach remains limited relative to the size of the global seafood trade. GAO found that FDA averaged 8,353 domestic and 917 foreign food-facility inspections per year from FY2018 through FY2023, and that about one in six food inspections during that period targeted seafood products. GAO also found that FDA had 432 investigators on board for domestic and foreign food inspections as of July 2024, with nearly one-quarter eligible to retire. And GAO’s seafood-import work found chronic weaknesses in import-alert removal oversight, including failure to audit 260 of 274 removal decisions and failure to conduct follow-up inspections before removing 31 of 32 firms with relevant OAI findings. The central point is not that FDA is absent; it is that the agency’s enforcement activity, while real, still operates under significant capacity constraints and with only partial public visibility.20
Sources and method
This report relies primarily on FDA primary sources: the Investigations Operations Manual, Regulatory Procedures Manual, Food Compliance Program 7303.842, FDA warning letters, import-alert pages, recall and advisory pages, FDA data and FOIA reading-room pages, and FDA’s current imported-seafood program materials. It also relies on GAO audit reports for independent assessment of inspection volume, sampling, and import-alert oversight, and one DOJ case as an example of escalation from administrative enforcement to litigation.1
Notes
FDA, Investigations Operations Manual; FDA, Regulatory Procedures Manual; FDA, Food Compliance Programs. ↩
FDA, FSVP Final Rule: What You Need to Know. ↩
FDA, FDA-TRACK Human Foods Program Compliance and Enforcement. ↩
FDA, Feng Foods Trading, Inc. Warning Letter; FDA, Rio Verde Food Service, Inc. Warning Letter; FDA, Maui Seafood, Inc. Warning Letter; FDA, FDA Advisory on Certain Imported Frozen Shrimp from Indonesia. ↩
FDA, Inspection Classification Database; FDA, Recalls, Market Withdrawals, & Safety Alerts; FDA, Inspection Observations; GAO, FDA Foreign Inspections and Workforce Report (GAO-25-107571); GAO, Seafood Safety: Better Oversight of Import Alert Removals Could Improve FDA’s Ability to Target Limited Resources. ↩
FDA, Seafood. ↩
FDA, Food Compliance Program 7303.842; FDA, FDA-TRACK Human Foods Program Compliance and Enforcement. ↩
FDA, FDA DNA Testing at the Wholesale Level to Evaluate Proper Labeling of Seafood Species; FDA, Economic Food Fraud. ↩
FDA, Food Compliance Program 7303.842. ↩
FDA, Import Alerts; FDA, Food Compliance Program 7303.842. ↩
GAO, Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources; GAO, Imported Seafood Safety: FDA and USDA Could Strengthen Efforts to Prevent Unsafe Drug Residues. ↩
FDA, Feng Foods Trading, Inc. Warning Letter. ↩
FDA, Rio Verde Food Service, Inc. Warning Letter; FDA, Maui Seafood, Inc. Warning Letter. ↩
FDA, Yongdae Hwangtae Union Corp. Warning Letter; FDA warning letters issued after foreign remote regulatory assessments involving seafood facilities in Nicaragua and Venezuela in 2025. ↩
FDA, FDA Advisory on Certain Imported Frozen Shrimp from Indonesia. ↩
FDA, FDA-TRACK Human Foods Program Compliance and Enforcement; U.S. Department of Justice, United States Files Complaint to Stop Massachusetts Company from Manufacturing and Distributing Adulterated Seafood Products. ↩
FDA, Search Databases; FDA, OII FOIA Electronic Reading Room. ↩
FDA, OII FOIA Electronic Reading Room. ↩
FDA, FDA-TRACK Human Foods Program Compliance and Enforcement; FDA, FDA to Expand Use of Unannounced Inspections at Foreign Manufacturing Facilities. ↩
GAO, FDA Foreign Inspections and Workforce Report (GAO-25-107571); GAO, Seafood Safety: Better Oversight of Import Alert Removals Could Improve FDA’s Ability to Target Limited Resources. ↩
Additional References
- FDA. “Seafood HACCP and FSMA.” www.fda.gov.
- 21 C.F.R. Part 123. www.ecfr.gov.
- GAO. Seafood Safety GAO-11-286. 2011. www.gao.gov.
- GAO. Imported Seafood Safety GAO-17-443. 2017. www.gao.gov.
- NOAA Fisheries. “Seafood Inspection Program.” www.fisheries.noaa.gov.
