To minimize the risk to consumers, operations, and supply chain, we meticulously inspect raw materials and test products throughout the manufacturing process to ensure consistent quality.
Kolmar USA is registered with the Food and Drug Administration (FDA registration #1000221288) as a manufacturer and packager of Over-The-Counter (OTC) pharmaceuticals and cosmetics and a registered drug manufacturer with the Pennsylvania Department of Health (Certificate #2000002231).
Kolmar USA follows current Good Manufacturing Practices (cGMPs) described in 21 CFR parts 211 (Current Good Manufacturing Practices for Finished Pharmaceuticals) in the manufacturing of the products produced at our facilities and as such are regularly inspected by the US FDA to that standard.
As a registered establishment, we are subject to the statutory inspections by the FDA and by the Quality Assurance Departments of our clients to verify compliance with cGMPs.
- Product Inspection
- Qualified and audited by third-party laboratories
- Method development and validation
- Forced degradation studies
- Final product release testing
- Dosing solution analysis for OTC
- Environmental Monitoring Program
- Cleaning/Sanitization Program Upgrades
- Cross-contamination prevention
- Equipment Upgrades and maintenance
- All raw materials entering our facility undergo meticulous inspection
ISO 22716:2007 Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices
Certification to ISO 22716 provides compliance to all of the recommendations of the Cosmetics GMP Guidelines through its approach to documentation and regulation of the production, control, conditioning, storage, and shipment of product.