FDA inspection readiness: GMP, QMSR and 483 response support
Our US FDA consultants help manufacturers design compliant facilities, implement GMP, prepare for FDA inspections and close out Form 483 observations — so you stay compliant and keep selling in the US.
What do our US FDA consultants do?
US FDA consultants help manufacturers meet FDA's current requirements so they can produce safe, high-quality medical devices, drugs, food, dietary supplements and cosmetics for the US market.
REGHELPS SRC brings together compliance, regulatory, scientific and technical experts. We find gaps early, fix them properly and document the evidence an FDA investigator expects to see — from facility layout through to post-inspection follow-up.
Medical devices: QSR is now QMSR
Since 2 February 2026, FDA's Quality System Regulation (21 CFR 820) has been replaced by the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference. FDA inspections of device makers are now carried out against the QMSR.
If your quality system was built for the old QSR, we run a QMSR gap assessment against ISO 13485:2016 and update your procedures, records and training so you are ready for your next inspection.
US FDA consulting services
Pick a single service or let us run your FDA compliance programme end to end.
FDA-compliant facility design
When a facility is the root of a compliance problem, fixing it later is slow and expensive. Our FDA consultants design layouts that address regulatory obstacles from day one — cleanroom zoning, material and personnel flow, segregation, storage and utilities.
We support medical device, drug, food and nutraceutical manufacturers, from new sites to expansions of existing plants.
Our FDA compliance process, step by step
- 1
Gap assessment
Week 1–2Review your facility, quality system and records against the 21 CFR part that applies to your products.
- 2
Remediation plan
Week 2–3A prioritised plan with owners, timelines and the evidence each fix needs to produce.
- 3
Implementation
VariesWrite or update SOPs, records and forms, validate processes and train your team.
- 4
Mock FDA inspection
Before the visitA realistic audit that tests documents, the shop floor and how your staff answer investigators.
- 5
Inspection support
During the visitFront-room and back-room support so requests are answered quickly and accurately.
- 6
Form 483 response
Within 15 business daysRoot-cause analysis, CAPA and a written response FDA can consider before deciding on further action.
- 7
Stay compliant
OngoingInternal audits, CAPA effectiveness checks and updates as FDA rules change.
FDA rules we support, by industry
Each product type has its own FDA quality rules. We work with manufacturers across all five.
| Industry | FDA regulation | What it covers | How we help |
|---|---|---|---|
| Medical devices | 21 CFR 820 (QMSR) | Quality management system, aligned to ISO 13485:2016 | QMSR transition, design controls, CAPA, mock inspections |
| Drugs | 21 CFR 210 & 211 | Current good manufacturing practice for finished pharmaceuticals | GMP systems, validation, batch records, inspection readiness |
| Food | 21 CFR 117 | CGMP, hazard analysis and risk-based preventive controls | Food safety plan, preventive controls, facility layout |
| Dietary supplements & nutraceuticals | 21 CFR 111 | CGMP for manufacturing, packaging, labelling and holding | Specifications, master and batch records, label review |
| Cosmetics | MoCRA (FD&C Act) | Facility registration, product listing, adverse event reporting, safety substantiation | Registration, listing and label review |
Official references: FDA's Quality Management System Regulation page and the Code of Federal Regulations, Title 21.
Built for zero-observation inspections
Our team has helped manufacturers worldwide pass FDA inspections with zero Form 483 observations — and turn around facilities that had open findings.
US FDA consultants FAQs
What do US FDA consultants do?
They help manufacturers meet FDA requirements: designing compliant facilities, setting up GMP or QMSR quality systems, preparing for FDA inspections and responding to Form 483 observations or Warning Letters.
Is the FDA QSR still in effect for medical devices?
No. Since 2 February 2026, 21 CFR 820 is the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference. Device manufacturers are now inspected against the QMSR.
How quickly should I respond to an FDA Form 483?
Aim to respond in writing within 15 business days. FDA may consider a timely, complete response before deciding whether to take further action, such as a Warning Letter.
What is a mock FDA inspection?
A realistic audit run by our consultants in the way an FDA investigator would. It finds gaps in documents, records and practice so you can fix them before the real inspection.
Do you provide label review?
Yes. We review labelling for food, drugs, cosmetics and medical devices against the applicable FDA requirements.
Do you work with manufacturers outside the US?
Yes. We support manufacturers worldwide that export to the US. Foreign establishments must also name a US Agent when registering with FDA, and REGHELPS can act as your US Agent.
Facing an FDA inspection or a Form 483?
Tell us about your products and site using the form below — we'll suggest the right next step at no cost.
