Contract Manufacturers, Compliance, Selection, and the FDA 

The FDA seldom gets involved in contract manufacturer selection.  They hold the top manufacturer responsible for selection and auditing to ensure they meet requirements. 

The key point the FDA focuses on is the part's specification, and thing they are most concerned with is that the part meets the specification  (print, material, method or manufacture, QC requirements, etc) . They require that you rank supplier by patient risk of the item they supply and document selection and periodic inspection / auditing.  

If the supplier's quality becomes unacceptable, they expect the company to have the systems in place to find that and resolve it, much under CAPA (Corrective and Preventive Action).  

Your choices of supplier should be ranked much as follows (1 is best):

1. FDA / CGMP, 21 CFR 820 compliant, and inspected by the FDA,

2.  ISO 13485:2016 compliant, and audited by a Notified-body;

3.  ISO 9001:2015 compliant, and audited by a Notified-body; 

3.  Actively working to be compliant in 1, 2 or 3;

4.  Know the basics of 820, or ISO 13485, or ISO 9001, especially change control, and willing to become compliant.   

Ultimately you should have a Quality Agreement on CGMP compliance signed by the selected company and yours.  

And the above will have to be defined by SOP, and with records to prove compliance.

-- jel@jelincoln.com

Added supplier to para 4.  JEL 05/12/24