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Adaptive immune responses, mediated by T and B cells, produce autoantibodies, including anti-citrullinated protein antibodies (ACPAs) and rheumatoid factor (RF), forming immune complexes that exacerbate synovial damage (13)

Outsourcing facilities are subject to CGMP requirements under section 501(a)(2)(B) of the FDCA. The Warning Letter included many of the top ten violations (see below) cited in FDA 483s issued to compounding pharmacies along with citations to the firm for manufacturing unapproved products

But if you suspect a storage issue AND notice reduced effectiveness, the most prudent action is to start with a fresh, properly stored supply and see if your results improve

Bompada, P

Nearly half of the participants retained clinically meaningful weight loss even after treatment ended