Quality and certifications
We hold ISO 9001, we are cGMP compliant, and we are FDA registered. Those are three separate things certifying three separate claims, and suppliers in this category run them together constantly. Here is what each one actually means, and what it does not.
ISO 9001
We hold this
A quality management systems standard. It certifies that our processes are documented, audited and repeatable — that the patch made in month twelve is made the same way as the patch made in month one.
It is not a GMP standard, and it says nothing about the product itself. Any supplier presenting ISO 9001 as "GMP equivalent" is stretching it, and your QA reviewer will know.
cGMP compliant
We hold this
Current Good Manufacturing Practice — the manufacturing conditions themselves: facility, hygiene, batch records, traceability, controls on how the product is actually made.
GMP is a practice standard, not a licence. It carries no claim about what a product does.
FDA registered
We hold this
Our facility is registered with the US Food and Drug Administration, which is a prerequisite for supplying that market.
Registration is a database entry, not an approval, and the FDA does not approve facilities. Any supplier who presents registration as approval is either careless or counting on you not knowing the difference.
Where your patches are made
Manufacturing runs in England and in Plzeň, Czech Republic, and the group operates US, UK, Irish and Czech entities. What that is worth depends on where you sell. Into the UK and the EU, it is both territories from one supplier instead of two. Into the US, it is European manufacture from FDA-registered facilities, with global tracked shipping.
Worth asking us, and worth asking anyone else you are considering: where does the coating physically happen, as distinct from where the company is registered. The two are frequently different.