FDA Inspections and Enforcement
PMA Pre-Approval Inspection Preparation
When FDA inspects a facility named in a PMA, it is checking two things: that the manufacturing and quality system described in the application is actually in place, and that the design and data in the submission are consistent with your records. We help you close the distance between the submission and the shop floor before an investigator measures it.
What You Receive
- 01PMA Consistency Findings
- 02Process Validation Findings
- 03Manufacturing Readiness Status
- 04Prioritized Action Plan
Every finding is reviewed and approved by a qualified QMS advisor before it reaches you.
What It Is
Premarket approval applies to Class III devices, and FDA's review of a PMA typically includes inspecting the manufacturing facilities named in it. Unlike a routine surveillance inspection, a pre-approval inspection is anchored to one device and one submission. The investigator compares your quality system and manufacturing process with what the PMA describes.
The weak points tend to sit at the seams: process validation completed for the submission but not maintained, a supplier listed in the PMA that has since changed, design history that doesn't reconcile with the design outputs or labeling in the application, or a production line that has moved on from the configuration described. Each is a question the investigator can ask, and your records have to answer it.
Our preparation focuses on that consistency. We review manufacturing readiness, process validation, supplier controls and design history against the relevant sections of your PMA, and we prepare the people who will explain them. Every finding is advisor-reviewed and goes into a tracked action plan.
When You Need It
- You've submitted, or are about to submit, a PMA and expect FDA to inspect your facility.
- Manufacturing has scaled or moved since the process validation work in the application was done.
- Suppliers, components or sites have changed since the PMA was drafted.
- Your design history was assembled for the submission and hasn't been reconciled since.
- A contract manufacturer named in the application needs to be ready for an investigator on its floor.
What We Do
- 01
Map the PMA to Your Records
We identify the manufacturing, quality system and design content in your PMA and map each element to the procedures and records that show it's in place.
- 02
Review Manufacturing Readiness
We look at production and process controls, equipment, environmental controls where relevant, acceptance activities and nonconformance handling on the line the application describes.
- 03
Check Process Validation
Validation protocols and reports are reviewed for completeness and for whether they still reflect the current process, equipment and suppliers.
- 04
Reconcile Design History With the Submission
Design inputs, outputs, verification, validation, risk management and design changes are compared with what the PMA describes, so inconsistencies surface before the investigator finds them.
- 05
Prepare the Inspection Team
We set up front room and back room roles and coach the engineers and quality staff who will explain the process and the validation work.
Deliverables
PMA Consistency Findings
Advisor-reviewed findings where your records, processes or suppliers differ from what the PMA describes, each tied to its source.
Process Validation Findings
Gaps in validation coverage, documentation or currency, sorted by severity.
Manufacturing Readiness Status
A readiness view of the production and quality processes the investigator is likely to examine.
Prioritized Action Plan
Owners, due dates and evidence requirements for every open item.
How the Platform Helps
Submission and Records in One Library
Upload the relevant PMA sections alongside your quality records, so a finding can cite both the application and the record that differs from it.
Evidence Review Before the Inspection
Owners submit evidence for each action, and the advisor accepts it or requests a revision, so you know which items are actually closed.
Immutable Activity History
A permanent record of each review decision, useful when you need to show how an inconsistency was resolved.
Audits and Inspections It Prepares You For
Standards and Regulations in Scope
Questions About This Service
Which devices go through a PMA pre-approval inspection?
PMA applies to Class III devices, and FDA's review typically includes inspecting the manufacturing facilities named in the application. Whether and how a given facility is inspected depends on your device, the application and FDA's review.
What is the investigator comparing?
Your actual manufacturing and quality system against what the PMA describes, and whether the design and data in the application are consistent with your records. Differences between the submission and practice are a common source of questions.
Does this replace preparation for routine inspections?
No. A pre-approval inspection focuses on one device and application. Routine surveillance inspections under CP 7382.850 look at your QMS more broadly, and we cover those under FDA Inspection Readiness.
Do you prepare contract manufacturers too?
Yes. If a contract manufacturer named in your PMA may be inspected, we can work with both parties on the records and processes that relate to your device, within the access your agreement allows.
Can you tell us when the inspection will happen?
No. Timing is set by FDA as part of its review. We focus on getting the manufacturing, validation and design records ready to be examined, whenever that is.
Request an Assessment
Discuss PMA Pre-Approval Inspection Preparation With an Advisor
Tell us about your devices, your documents and your timeline, and an advisor will scope the work with you. Please don't send confidential documents yet: secure upload is set up after onboarding.
