FDA and EMA Approved Manufacturing Sites: Manufacturing Insurance for Regulated Facilities (UK Guide

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FDA and EMA Approved Manufacturing Sites: Manufacturing Insurance for Regulated Facilities (UK Guide

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FDA and EMA Approved Manufacturing Sites: Manufacturing Insurance for Regulated Facilities (UK Guide)

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Learn what insurance FDA/EMA-approved manufacturing sites need in the UK—product liability, recall, property, BI, cyber, and regulatory risks.

Introduction

If you operate a manufacturing site that’s approved by the FDA (US Food and Drug Administration) and/or the EMA (European Medicines Agency), you’re not just running a factory—you’re running a regulated environment where quality systems, traceability, and compliance are central to everything you do.

That same reality should shape your insurance programme.

Standard “manufacturing insurance” can be too generic for regulated sites. FDA/EMA-approved facilities face higher-value product risks, stricter documentation expectations, and more complex supply chains. A single deviation, contamination event, or equipment failure can trigger product holds, field actions, recalls, or contractual penalties—often before you’ve even confirmed the root cause.

This guide explains the core insurance covers FDA/EMA-approved manufacturing sites typically need, the exposures insurers will ask about, and how to structure a policy that matches regulated manufacturing.

What “FDA/EMA-approved site” means from an insurance perspective

Regulatory approval is a positive signal to insurers because it suggests mature quality management systems (QMS), validated processes, and controlled environments. But it also means:

  • Higher consequence of failure: Products are often used in healthcare or other safety-critical settings.

  • Tighter tolerances: Small deviations can lead to batch rejection or market withdrawal.

  • More stakeholders: Contract manufacturers, brand owners, distributors, notified bodies, auditors, and regulators.

  • More documentation: If something goes wrong, you must prove what happened, when, and why.

Insurers tend to focus less on “are you approved?” and more on how you maintain compliance day-to-day and how quickly you can contain incidents.

Key risks for FDA/EMA-approved manufacturing sites

Regulated manufacturing risks are a blend of operational, product, and compliance exposures.

1) Product defects and patient/user harm

Even with strong QA, defects can occur due to:

  • Raw material issues

  • Process drift

  • Supplier non-conformance

  • Labelling/IFU errors

  • Sterilisation failures

  • Packaging integrity issues

If a defect causes injury, illness, or property damage, you can face claims, legal costs, and reputational damage.

2) Product recall and field actions

Recalls and field actions can be triggered by:

  • Confirmed defects

  • Suspected contamination n- Stability failures

  • Adverse event trends

  • Regulatory findings

Costs can include notification, logistics, destruction, rework, replacement, and specialist consultants.

3) Contamination and cross-contamination

Cleanrooms, controlled environments, and validated cleaning reduce risk—but contamination events can still happen via:

  • HVAC failures

  • Gowning breaches

  • Inadequate cleaning validation

  • Water system issues

  • Pest ingress

Contamination can lead to batch loss, shutdowns, and expensive investigations.

4) Equipment breakdown and validation impacts

Regulated sites rely on critical equipment such as:

  • Autoclaves and sterilisers

  • Filling lines

  • Environmental monitoring systems

  • Freezers and cold rooms

  • PLC/SCADA systems

When equipment fails, the impact isn’t only repair cost—it’s revalidation, downtime, and potential product loss.

5) Business interruption and supply chain disruption

A fire, flood, or equipment failure can halt production. For regulated sites, restart can be slower because:

  • You may need to requalify equipment

  • You may need to repeat validation runs

  • You may need regulatory notifications

Supply chain disruption is also common—especially for single-source components, specialist raw materials, or sterile packaging.

6) Regulatory investigations and compliance costs

If regulators investigate (or if you self-report), you may need:

  • Specialist legal advice

  • Quality and regulatory consultants

  • Forensic engineering

  • Crisis communications

Some of these costs can be insured depending on policy wording.

7) Cyber risk and operational technology (OT) exposure

Manufacturing sites increasingly depend on connected systems:

  • Batch records (electronic)

  • ERP/MRP systems

  • LIMS and QMS platforms

  • OT networks controlling equipment

A cyber incident can cause production stoppage, data loss, or integrity concerns—especially if batch records or audit trails are affected.

Core insurance covers to consider

Below are the covers most FDA/EMA-approved manufacturing sites typically review. The right mix depends on whether you are a brand owner, contract manufacturer, component supplier, or a combination.

1) Product liability and public liability

Product liability is often the cornerstone for regulated manufacturers. It can cover:

  • Compensation for third-party injury/illness

  • Third-party property damage

  • Legal defence costs

Public liability covers incidents arising from your premises/operations (e.g., visitor injury).

Watch-outs for regulated sites:

  • Territorial limits (UK/EU/Worldwide) and jurisdiction (including USA/Canada)

  • Contractual liability (what you’ve agreed in supply contracts)

  • Exclusions relating to known defects or failure to comply with regulations

If you supply into the US, product liability structure becomes even more important due to litigation risk.

2) Product recall / contamination cover

Product recall insurance is designed to help with costs of removing products from the market.

Typical insured costs may include:

  • Customer notification and call centres

  • Transport, warehousing, and disposal

  • Replacement or refund costs (varies)

  • Specialist consultants (QA/regulatory)

Some policies also include contamination or malicious tampering extensions.

Key question: Are you insuring first-party recall costs only, or also third-party recall liability (where a customer claims their recall costs from you)?

3) Professional indemnity (PI) / errors & omissions

If you provide design input, specifications, validation services, regulatory support, or consultancy as part of your manufacturing service, PI can be relevant.

Examples:

  • Incorrect validation protocol leading to unusable batches

  • Documentation errors causing regulatory non-compliance

  • Incorrect advice on packaging/sterility requirements

PI is often overlooked by manufacturers who assume product liability covers everything—it doesn’t.

4) Property damage (buildings, contents, stock)

Property insurance covers physical loss/damage from insured perils such as fire, flood, storm, escape of water, and more.

For regulated sites, you’ll want to ensure:

  • Sum insured reflects replacement cost (including specialised fit-out)

  • Stock valuation includes high-value WIP and finished goods

  • Temperature-controlled stock is properly declared

5) Business interruption (BI)

BI covers loss of gross profit and increased cost of working following insured property damage.

For FDA/EMA-approved sites, BI should be designed around:

  • Longer restoration timelines due to revalidation

  • Dependency on utilities (power, water, steam)

  • Critical machinery lead times

Practical tip: Consider a longer indemnity period than a typical manufacturer, especially if you have single-site production.

6) Equipment breakdown (engineering insurance)

Also called machinery breakdown, this can cover:

  • Sudden and accidental breakdown of insured equipment

  • Repair/replacement costs

  • Optional BI from breakdown

This is crucial where a single piece of equipment can stop production or compromise validated conditions.

7) Employers’ liability (EL)

In the UK, EL is compulsory for most employers. It covers injury/illness claims from employees.

Regulated sites may have additional exposures:

  • Handling chemicals/solvents

  • Cleanroom working conditions

  • Repetitive strain and manual handling

8) Cyber insurance

Cyber cover can help with:

  • Ransomware response and negotiation

  • System restoration and forensic investigation

  • Business interruption from cyber events

  • Data breach response (GDPR)

For manufacturing, ensure the policy addresses operational disruption, not only data privacy.

9) Directors’ and officers’ (D&O)

D&O can protect directors and senior management against claims alleging wrongful acts in management.

This can be relevant where:

  • Investors are involved

  • There are allegations of mismanagement following a major incident

  • Regulatory scrutiny escalates

10) Cargo / transit insurance

If you ship high-value or temperature-sensitive goods, transit cover can protect against loss/damage in transit.

Consider:

  • Cold chain failures

  • Courier liability limits (often inadequate)

  • International shipments and customs delays

What insurers typically ask (and why)

Expect detailed underwriting questions. Strong answers can improve terms.

Quality and compliance

  • Which standards do you operate to (e.g., ISO 13485, GMP)?

  • Audit history and outcomes

  • CAPA process maturity

  • Deviation and change control procedures

Traceability and documentation

  • Batch record controls (paper vs electronic)

  • Data integrity controls (audit trails, access management)

  • Retention periods

Supplier and subcontractor controls

  • Approved supplier list and qualification process

  • Incoming inspection and testing

  • Reliance on single-source suppliers

Recall readiness

  • Written recall plan and testing frequency

  • Ability to identify affected lots quickly

  • Crisis management team and external advisors

Plant resilience

  • Fire protection (sprinklers, compartmentation)

  • Flood risk management

  • Backup power and utilities

  • Preventative maintenance and calibration

Cyber and OT security

  • Network segmentation between IT and OT

  • Backups and recovery testing

  • MFA and privileged access controls

  • Incident response plan

Common gaps and how to avoid them

These are issues we often see when regulated manufacturers rely on “standard” policies.

  • USA exposure not declared: If products end up in the US, you need correct territory/jurisdiction.

  • Recall not included: Product liability doesn’t automatically pay recall costs.

  • Contractual liabilities ignored: Supply contracts can push recall costs onto you.

  • Underinsured stock and WIP: Regulated inventory can be far more valuable than expected.

  • BI indemnity period too short: Revalidation can extend downtime.

  • Cyber policy focused only on data: Manufacturing needs operational disruption cover.

How to structure a strong insurance submission

A good submission can reduce friction and improve pricing.

Include:

  • Short company overview (what you make, who you supply)

  • Regulatory footprint (FDA/EMA approvals, audit cadence)

  • Claims history and lessons learned

  • Quality metrics (complaints, deviations, CAPA closure times)

  • Recall plan summary and mock recall results

  • Business continuity plan and key dependencies

  • Cyber controls overview (especially OT)

If you’re a contract manufacturer, be clear about:

  • Where your responsibility ends (brand owner vs manufacturer)

  • Who controls labelling and IFUs

  • Who holds regulatory approvals

Choosing limits: practical considerations

There’s no universal “right” limit, but you can sanity-check your programme against:

  • Worst-case injury scenario (severity and jurisdiction)

  • Largest customer contract requirements

  • Maximum batch value and potential recall scope

  • Maximum downtime exposure (weeks/months)

For regulated sites, it’s often better to build a programme that can handle a low-frequency, high-severity event.

Final thoughts

FDA and EMA approval signals a high standard of manufacturing control—but it also raises the stakes when something goes wrong. The right insurance programme should mirror how regulated sites actually operate: validated processes, strict documentation, high-value stock, complex supply chains, and the potential for recalls and long downtime.

If you want, tell me what you manufacture (medical devices, pharma, components, sterile packaging, etc.), whether you sell into the US, and whether you’re a brand owner or contract manufacturer—and I’ll tailor the cover priorities and a suggested insurance checklist for your exact setup.

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