The FDA put my welder in detention…. Before the field inspection report was finished, some Safety bureaucrat in DC sent an email to the west coast head cheese in Long Beach . He sent me an email declaring the machine is non compliant with 5 different federal regulations. They had not even seen the report that too Five Hours for the inspector to do. He has not submitted it. Best of all the report no longer counts, I am DETAINED.. Seems my import papers, don’t match a DATA BASE somewhere. So now I am on double secrete probation. I have until 18 July to get into compliance or return or destroy the welder. And best of all the only thing they will tell me is the 5 things…… no details…
- Noncompliant Product Report - 21 CFR 1002.10
- Noncompliant Certification - 21 CFR 1010.2
- Noncompliant Identification - 21 CFR 1010.3
- Noncompliant Required Labeling - 21 CFR 1040.10(g)
- Noncompliant User Information - 21 CFR 1040.10(h)
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