FDA Registered and ISO Certified.
WHK is FDA Registered as a Medical Device Manufacturer and is ISO 13485 Certified.
Our Quality Management System exceeds FDA Quality System Regulations (cGMP), and includes:
- Qualification of all suppliers
- Supplier Quality Agreements
- Raw material and component sourcing, certification & regulatory compliance
- Equipment and tooling IQ, OQ and PQ
- Lot traceability for material and labor, from receiving to shipping
- Material review board
- Internal/external auditing
- Environmental particulate and microbial monitoring
- Risk assessment and mitigation for raw components & manufacturing processes
- Assistance with filing 520(k)'s, Drug Master File, and Material Master File
- Manage and oversee gamma irradiation and sterilization
- Product stability and leak testing
- Acceptance quality levels based on ANSI/ASQ Z1.4
- FDA Pharmaceutical packaging requirements
For More Information: Contact Customer Service at 855-WHK-BIO1 (855-945-2461) or 727-209-8400 or E-Mail Us Here.