1. Crescent Industries has the following quality certifications and facility registrations: FDA Registered, ISO 13485:2003 & ISO 9001:2008 Certified, ITAR, Federal Firearms License.
2. Project Management utilizing Project Realization Workflow outlining each step of the project from mold design to production.
3. Design & Process Failure & Effects Analysis- This documents a systematic approach to recognize and evaluate potential failures in a design or process and its effect on downstream processes.
4. Validated ERP System – This means Crescent’s ERP system has been certified by a third party and complies with FDA mandates including cGMP and 21 CFR Part 11. This system is used to track orders from incoming raw materials through production for lot traceability.
5. Validations – process validations qualifications using IQ, OQ & PQ which is establishing controls for processes for installation of a mold, operation of mold and performance (including all statistical analysis associated like: DOE and Capabilitiy studies).
6. Multiple locations – Cresent has three manufacturing facilities located in New Freedom, PA
7. CNC Quality inspection and video inspection equipment - Our quality team utlizies these types of inspection machines to verify critical dimensions on first articles, production samples or entire runs.
Crescent Industries is your integrated manufacturing solution for your next project!