Formed in 2002 outside Albany, Extreme Molding is a women-owned U.S. manufacturer of precision silicone injection-molded components for demanding consumer and healthcare products. Its full-service New York operation takes products from tooling and molding through assembly, packaging, and fulfillment, with particular experience in women’s healthcare and infant products. The company employs 75–100 people across three shifts and operates with ISO 9001:2015 and ISO 13485:2016 certification, FDA registration, and full manufacturing traceability.
ISO 9001:2015
ISO 13485:2016
FDA Registered Facility
Registration
QRS Compliance
Compliance program
CGMP
Compliance program
TQMS
Compliance program
USP Class VI Certified Materials
FDA 21 CFR 177.2600
Compliance program
Women-Owned Business
FDAREGISTRATION
Quality certification
QRS
Quality certification