Quality Assurance

Thermo-Pak Co., Inc. stresses quality in every step of the process. Good Manufacturing Practices are strictly adhered to as detailed in our Standard Operating Procedures. All employees are regularly trained in GMP as they apply to their job. The Thermo-Pak Co., Inc. facility is regularly audited by the FDA and has not had any 483 observations. Blister manufacturing validation is performed for each drug product packaged. Quality attributes are continually monitored during production to assure that these parameters remain within the validated ranges.

Certifications Include:

• Licensed wholesale drug distributor and repackager
• Registered for the manufacture of controlled substances: 3, 3N, 4 and L1
• FDA approved
• cGMP compliant