Will Becoming a DAMAS Laboratory Lead to an FDA Inspection?

This is most definitely not true.  Every laboratory, whether based within the USA or off shore, producing dental appliances for the USA market, must satisfy the relevant sections of the obligatory FDA Good Manufacturing Processes (GMP) requirements.   These are detailed in the FDA document CFR Part 820.  All dental laboratories are liable to be subjected to an FDA inspection.

There is no more reason why the FDA should select a DAMAS certified laboratory than any other laboratory for an inspection.   In fact the reverse is most probably the case.  The DAMAS system meets the requirements of the FDA GMP and the laboratory can show evidence of satisfying this requirement by means of their registration as a DAMAS certified organization.

DAMAS certification is undertaken by an internationally accredited registration authority, namely AJA Registrars. This 3rd party certification, which is commonly known as a systems audit, is conducted according to strict international guidelines by qualified and registered auditors. The same auditing rules also apply to any labs having achieved ISO9001 certification.

Once certified to DAMAS the lab is presented with a certificate of registration.  Both AJA Registrars and the NADL hold a record of all DAMAS certified laboratories.

When one considers the large number of dental labs within the USA it becomes obvious that for the FDA to inspect them all would be a massive task.   I would suggest that any lab demonstrating compliance to the FDA GMP requirement by means of 3rd party certification would be the least likely to be included into the FDA inspection program.

Of course should a laboratory, whether DAMAS certified or not, show just cause for an FDA inspection by for instance, malpractice, then an FDA inspection would be mandatory.  One of the advantages of DAMAS certification is that systems are in place to ensure that such a circumstance should not arise.

Should the FDA prove my assumption incorrect by selecting a DAMAS certified lab for inspection, the systems needed to meet the GMP requirement are not only in place but are proven by the 3rd party audit to be satisfactory. 

The only labs that have to worry about an FDA inspection are those who do not have a proven GMP system and do not meet the obligatory GMP requirement.