Before 2016, the FDA routinely inspected nearly all registered medical device contract manufacturers every two years. Now, the FDA prioritises and schedules surveillance inspections based on risk factors, such as device classification and the facility's compliance history.
As a result, not every FDA-registered contract manufacturer will have been routinely inspected by the regulator even though they are already manufacturing products for the US market.
But before we go any further, let’s define what we mean by a routine inspection.
What are the 4 types of FDA inspection?
The FDA conducts four main types of inspections:
1. Pre-Approval Inspections (PAI): Verifies data submitted in applications for new devices, ensuring compliance with regulations before market approval.
2. For-cause inspections: Targeted inspections initiated due to reported issues, complaints, or previous violations to investigate potential problems.
3. Routine inspections: Scheduled surveillance inspections to confirm compliance with Good Manufacturing Practices (GMP) for facilities that produce FDA-regulated products.
4. Compliance follow-up inspections: Follow-up inspections to verify that previous violations have been corrected and that the facility now meets FDA standards.
So, surveillance inspections are not triggered by any specific event, but they are intended to test the readiness and rigour of a facility’s quality management system to consistently meet quality standards and proactively identify potential issues with end products.
Here’s the value of choosing a medical device manufacturing partner who has already passed a routine, surveillance inspection with no findings.
What happens during a FDA surveillance inspection?
When the FDA routinely inspect a contract manufacturer, the CM must give full access to a team from the US to access their facilities, production lines and the documentation in their QMS (Quality Management System).
During an inspection the entire facility's operations are scrutinised over several days.
At ESCATEC, preparing for a recent FDA surveillance inspection proved a comprehensive and time-intensive effort. CEO of ESCATEC Charles-Alexandre Albin described the process involved:
"The FDA inspectors were here for four days, but preparing for this audit took nearly a month. We took the inspection very seriously and ensured the team had everything they needed whilst they were here.”
Key stages of FDA contract manufacturer surveillance inspection
Typically, a surveillance inspection looks at everything from design control to distribution, but the latest FDA inspection of ESCATEC was for products where there was no design input from the CM, so the visit focused on the production process.
Routine FDA inspections follow a systematic approach known as the Quality System Inspection Technique (QSIT).
Inspecting a manufacturing facility - how the process works
Teams begin by examining the specific products the supplier manufactures, tracing back through the processes to ensure that every production step aligns with the documented process and the FDA's quality standards.
Inspectors analyse the Device History Records (DHR), which detail the complete production history of the device, including dates, times, personnel involved, and the specific processes followed.
They then compare these records with the team’s Standard Operating Procedures (SOPs) to verify that the manufacturing steps were executed according to the approved guidelines and in line with Good Manufacturing Practice (GMP).
They also review any Non-Conformance and CAPA Reports to check how issues were handled during production, ensuring that any deviations were properly managed and that corrective actions were effective.
Finally, they assess validation and verification reports to confirm that processes consistently produce devices that meet all required specifications.
As Teng Mei Fong, ESCATEC Medical’s Quality Manager, points out:
“They drill down into your records to ensure traceability. Every process, every timestamp must be documented and accurate because it proves that the product has been manufactured in the required way.”
The FDA inspect end-to-end operations
But it should be noted that when a manufacturer is inspected by FDA, it’s not just the QMS and production lines of their FDA listed products that can be looked into by the regulator.
In fact, the regulator has the power to examine all the products produced by the establishment and their associated documentation, regardless of whether they are destined for the US market, to ensure that the facility has a holistic, end-to-end, risk-based quality approach in place.
What happens post-inspection?
After the inspection, the FDA provides feedback, highlighting any findings. This could range from minor, verbal comments to more significant findings documented on a Form 483.
ESCATEC are currently awaiting formal notification from the FDA before we are able to publish the outcome of the inspection.
Preparing for and managing a routine FDA surveillance inspection requires organisation and rigour, it is the ultimate test of a company’s Quality Management System that not every business survives unscathed.
It’s important to remember when selecting a partner to manufacture your medical device, it’s your responsibility to ensure they can meet the rigorous quality standards laid out by the FDA in the QMSR.
As American regulatory expert Alan Schwartz of mdi Consultants points out:
“The FDA expects that the OEM will view the contract manufacturer as an extension of its own operations.”
Choosing a contract manufacturer who has had their establishment routinely inspected without any major findings, will bring extra reassurance to those looking to further de-risk their selection process.
