A
Hello,
We are classified as a "component manufacturer" through the FDA and are ISO 9001 & 13485 certified. The FDA scheduled an audit of our facility, within the first hour the inspector realized that we are indeed a component manufacturer and decided that the audit did not need to be completed. However, the auditor suggested that we become cGMP compliant...
So I've been researching... I came across a statement "if you are 13485 certified, you are cGMP compliant". Can anyone tell me if that is a true statement and recommend some type of training program or facility that we could look into?
Thank you in advance,
Amanda
We are classified as a "component manufacturer" through the FDA and are ISO 9001 & 13485 certified. The FDA scheduled an audit of our facility, within the first hour the inspector realized that we are indeed a component manufacturer and decided that the audit did not need to be completed. However, the auditor suggested that we become cGMP compliant...
So I've been researching... I came across a statement "if you are 13485 certified, you are cGMP compliant". Can anyone tell me if that is a true statement and recommend some type of training program or facility that we could look into?
Thank you in advance,
Amanda
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