FDA compliance is not a one-time project — it is a continuous obligation. From annual registration renewals and adverse event reporting to labeling reviews and recall readiness, we manage the full spectrum of post-market regulatory requirements so you stay compliant year after year.
Jared Clark, JD, MBA, PMP, CMQ-OE, RAC, CPGP, CFSQA
For broader quality and compliance consulting across ISO and GMP standards, visit our parent practice at certify.consulting.
Getting your product to market is only the beginning of your FDA regulatory journey. The moment your product enters commercial distribution, a new set of ongoing obligations takes effect — and these obligations never expire. Annual registration renewals, adverse event reporting, labeling updates, recall readiness, post-market surveillance, and supply chain integrity are all continuous requirements that demand sustained attention.
Most FDA enforcement actions — warning letters, consent decrees, import alerts, and product seizures — are not triggered by initial registration errors. They are triggered by ongoing compliance failures: missed adverse event reports, lapsed registrations, outdated labeling, inadequate recall procedures, or incomplete post-market surveillance. These are the gaps that accumulate quietly over months and years, then surface during an FDA inspection or audit with potentially devastating consequences.
An FDA compliance consultant serves as your long-term regulatory partner, ensuring that every post-market obligation is monitored, managed, and documented. Unlike one-time consulting engagements that end when a specific project is complete, compliance management is an ongoing relationship that evolves with your business, your product portfolio, and the regulatory landscape.
The compliance gap problem: Companies that invest heavily in initial registration and market clearance but neglect ongoing compliance are the ones most likely to receive warning letters. FDA investigators expect to see active, maintained compliance systems — not documentation that was created at launch and never updated. We close that gap with continuous, proactive compliance management.
A comprehensive compliance program touches every aspect of your post-market regulatory obligations. Here is what we manage for our clients on an ongoing basis.
Annual and biennial renewal management across all FDA-regulated product categories.
MedWatch, FAERS, and MDR submission management with deadline tracking.
Ongoing labeling reviews against current FDA requirements and guidance documents.
Recall SOPs, mock recall exercises, and real-time recall management support.
Promotional material review for FDA compliance, including digital and print advertising.
Risk Evaluation and Mitigation Strategy program management and FDA reporting.
Drug Supply Chain Security Act compliance for pharmaceutical track-and-trace requirements.
Continuous monitoring of product safety signals, complaint trends, and regulatory changes.
Every FDA-registered establishment must renew its registration on a defined schedule. For drug and medical device establishments, renewal is required annually between October 1 and December 31. For food facilities under FSMA, biennial renewal is required during even-numbered years within the same October–December window. Missing these deadlines is not a minor administrative oversight — it causes your registration to lapse, which can trigger import alerts, product detention, and FDA enforcement actions.
Our registration renewal management service ensures that no deadline is ever missed. We maintain a rolling calendar of renewal dates for every client facility, initiate the renewal process well in advance of the deadline, verify that all facility and product listing information is current, and confirm successful renewal with the FDA's electronic systems. For drug and device establishments, we also track and manage the annual registration fees required under PDUFA, GDUFA, and MDUFA.
Beyond simply renewing your registration, we use the renewal cycle as an opportunity to audit your complete regulatory profile. This includes verifying that all product listings are accurate and current, confirming that your establishment's activities match what is reported to the FDA, updating U.S. Agent designations for foreign facilities, and identifying any changes in your operations that may require updated registrations or new registrations.
Consequence of lapsed registration: If your registration lapses, the FDA considers your facility unregistered. Products manufactured at or distributed from an unregistered facility are considered adulterated under federal law. For imported products, this means automatic detention at the border. We have never allowed a client's registration to lapse.
Adverse event reporting is one of the most critical and time-sensitive FDA compliance obligations. When a patient, healthcare provider, or consumer reports an adverse experience associated with your product, you have a legal obligation to evaluate the report and, in many cases, submit it to the FDA within strict timeframes. Failure to report — or late reporting — is one of the most common triggers for FDA warning letters and enforcement actions.
Drug manufacturers and holders of approved applications (NDA, ANDA, BLA) are required to report adverse drug experiences to the FDA through the FDA Adverse Event Reporting System (FAERS). The reporting requirements are defined in 21 CFR 314.80 (for approved drugs) and 21 CFR 310.305 (for marketed drugs without approved applications):
Medical device manufacturers are required to report adverse events under the Medical Device Reporting (MDR) regulation (21 CFR Part 803). MDR reports are mandatory when a device may have caused or contributed to a death or serious injury, or when a device has malfunctioned in a way that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur:
We establish and maintain your complete adverse event reporting infrastructure. This includes developing intake procedures for receiving adverse event reports from all sources (patients, healthcare providers, sales representatives, social media monitoring), creating evaluation criteria for assessing reportability and seriousness, building submission workflows with deadline tracking and escalation protocols, and managing all regulatory submissions through MedWatch, FAERS, and the eMDR system. We also train your internal staff on their responsibilities for adverse event identification and initial documentation.
Proactive monitoring: Beyond mandatory reporting, we monitor emerging safety signals across your product portfolio. This includes tracking complaint trends, reviewing published literature, and analyzing FAERS and MAUDE database entries related to your products and therapeutic areas. Early signal detection enables proactive risk management before issues escalate.
No company plans to issue a product recall, but every FDA-regulated company must be prepared for one. The FDA expects manufacturers to have documented recall procedures that can be executed rapidly when a product safety issue or quality defect is identified. Recall readiness is not optional — it is an integral component of your quality system and a frequent area of focus during FDA inspections.
Product recalls are classified by the FDA into three categories based on the severity of the health hazard:
Our recall readiness program includes developing comprehensive recall SOPs specific to your product type and distribution channels, establishing a recall team with defined roles and communication protocols, creating customer notification templates for each recall class, building distribution traceability systems to enable rapid identification of affected product lots, conducting mock recall exercises to test response times and process effectiveness, and managing FDA recall communications including RES (Recall Enterprise System) submissions and progress reports.
When a recall is necessary, we manage the entire process from initial health hazard evaluation through recall strategy development, FDA notification, customer communication, product retrieval or correction, and recall effectiveness checks. Our goal is to execute the recall efficiently while minimizing business disruption and protecting your FDA relationship.
FDA recall authority: Under FSMA, the FDA has mandatory recall authority for food products. For drugs and devices, recalls are technically voluntary — but the FDA can pursue court-ordered seizure or injunction if a company refuses to recall. Prompt, well-managed voluntary recalls demonstrate good faith and are viewed favorably by the FDA during subsequent interactions.
FDA labeling requirements are among the most detail-intensive regulatory obligations that manufacturers face — and they are not static. Labeling regulations evolve, FDA guidance documents are updated, and your own product information changes over time. A label that was compliant at launch can become non-compliant within a year if it is not actively maintained.
Labeling non-compliance is one of the top five most cited observations on FDA Form 483s across all product categories. Common labeling deficiencies include outdated active ingredient information, missing or incorrect NDC numbers, failure to include required warning statements, non-compliant Supplement Facts panels for dietary supplements, missing Unique Device Identifier (UDI) information for medical devices, and inadequate directions for use.
We provide ongoing labeling compliance management that includes:
Every claim you make about your FDA-regulated product — whether in print advertising, digital marketing, social media, sales presentations, or website copy — is subject to FDA regulation. The FDA's Office of Prescription Drug Promotion (OPDP) and the Division of Industry and Consumer Education (DICE) actively monitor promotional materials for compliance violations, and enforcement actions for promotional non-compliance have increased significantly in recent years.
Promotional compliance violations include false or misleading claims, omission of risk information, broadening of indications beyond approved uses (off-label promotion), unsubstantiated comparative claims, and failure to include required fair balance information. These violations can result in FDA warning letters, untitled letters, and referrals to the Department of Justice.
Our review process evaluates every piece of promotional material against the approved labeling (for drugs and devices), applicable FDA guidance documents, and current enforcement precedents. We provide clear, actionable feedback on what needs to change and why, helping your marketing team move quickly while staying compliant.
A Risk Evaluation and Mitigation Strategy (REMS) is an FDA-required program designed to manage known or potential serious risks associated with a drug product. When the FDA determines that a REMS is necessary to ensure that the benefits of a drug outweigh its risks, the manufacturer must develop, implement, and maintain the REMS program as a condition of approval.
REMS programs can range from simple Medication Guides to complex programs with Elements to Assure Safe Use (ETASU) that may include prescriber and pharmacy certification requirements, patient registries, restricted distribution systems, and mandatory laboratory monitoring. The operational complexity of maintaining a REMS program should not be underestimated — and the consequences of non-compliance are severe, including withdrawal of product approval.
Shared REMS: For products subject to shared REMS programs (where multiple manufacturers of the same drug participate in a single REMS), we manage your company's obligations within the shared system while coordinating with the lead REMS holder as needed.
The Drug Supply Chain Security Act (DSCSA), enacted as Title II of the Drug Quality and Security Act of 2013, establishes a national system for tracing prescription drug products through the pharmaceutical supply chain. DSCSA compliance is mandatory for all participants in the drug supply chain — manufacturers, wholesale distributors, dispensers (pharmacies), and repackagers.
The DSCSA requires companies to exchange transaction information (TI), transaction history (TH), and transaction statements (TS) each time ownership of a prescription drug product changes hands. As of November 2024, the enhanced drug distribution security requirements under DSCSA Section 582(g) require manufacturers and other supply chain participants to implement systems capable of unit-level product tracing using standardized numerical identifiers (SNIs) encoded in product-level barcodes.
DSCSA enforcement: The FDA has been actively enforcing DSCSA requirements with increasing rigor. Companies that have not implemented compliant serialization and unit-level tracing face potential enforcement actions including warning letters, import alerts, and civil monetary penalties. We help you build and maintain a compliant supply chain program that satisfies both FDA and trading partner requirements.
Post-market surveillance is the systematic monitoring of product safety and performance after a product enters commercial distribution. While the FDA conducts its own post-market surveillance activities, manufacturers have independent obligations to monitor their products and report safety signals to the FDA.
For medical devices, the FDA may require formal post-market surveillance studies under Section 522 of the FD&C Act for certain Class II and Class III devices. These studies must be designed and conducted according to FDA-approved protocols and can span multiple years. Even without a formal 522 order, all device manufacturers must maintain complaint files and conduct trend analysis under their quality management systems.
For drugs, post-market surveillance activities include monitoring FAERS data, conducting post-marketing studies and clinical trials required as a condition of approval (sometimes called Phase IV commitments or post-marketing requirements), and tracking published medical literature for new safety information about your active ingredients.
We do not believe in one-and-done consulting engagements for compliance work. Regulatory compliance is an ongoing obligation, and it deserves an ongoing relationship with a consultant who knows your business.
You work directly with Jared Clark — not a rotating cast of junior associates. Your compliance partner understands your products, your history, and your regulatory profile.
We do not wait for problems to surface. We monitor regulatory changes, track deadlines, and identify compliance gaps before they become enforcement actions.
Our long-term compliance clients do not need separate inspection preparation engagements because they are always in a state of inspection readiness.
As your product portfolio grows, your compliance program scales with it. We adjust scope, reporting, and monitoring as your business evolves.
With credentials spanning drugs (CPGP), food safety (CFSQA), and regulatory affairs (RAC), we cover compliance requirements across all FDA-regulated product categories.
Ongoing compliance management costs a fraction of what a single warning letter remediation or recall event would cost. Prevention is always cheaper than reaction.
FDA compliance management works best as part of a comprehensive regulatory strategy. These related services complement your ongoing compliance program.
Explore our complete range of FDA regulatory consulting services — from initial registration through ongoing compliance and enforcement response.
View all servicesMock inspections, documentation review, and real-time inspection support. Our compliance clients are always inspection-ready, but we offer standalone preparation as well.
Learn moreFacility registration and product listing for drug, device, and food establishments. Many of our registration clients transition into ongoing compliance management.
Learn moreCommon questions about ongoing FDA compliance, adverse event reporting, and long-term regulatory management.
Stop managing FDA compliance reactively. Schedule a free consultation with Jared Clark, RAC — we will assess your current compliance posture and design an ongoing program that keeps you ahead of every deadline, every reporting requirement, and every inspection.