The Light of Belief Behind Zero 483: Elab Empowers Zhejiang Chemsyn Pharm Co., Ltd. to Successfully Pass FDA On-Site Inspection

The Light of Belief Behind Zero 483: Elab Empowers Zhejiang Chemsyn Pharm Co., Ltd. to Successfully Pass FDA On-Site Inspection

Blockbuster News

After a rigorous week-long inspection, Zhejiang Chemsyn Pharmaceutical Co., Ltd. achieved outstanding results with zero 483 observations, successfully passing the U.S. FDA’s Pre-Approval Inspection (PAI)! With Elab’s end-to-end support, this milestone marks a "breakthrough" moment for a Chinese pharmaceutical company in the high-end active pharmaceutical ingredient (API) sector!

Overcoming Challenges, Delivering on the Mission

The inspection covered six critical systems, including production, quality, and laboratory systems, with exceptionally stringent standards. Through close collaboration between Elab and Zhejiang Chemsyn, the team executed a high-standard preparation and ultimately delivered a flawless performance!

"We do not persist because we see hope; we see hope because we persist."

Success is never accidental—it is the culmination of countless days and nights of dedication and perseverance. Throughout the project, the team faced numerous challenges, but by upholding the belief in "professionalism, focus, and the pursuit of excellence," they overcame every obstacle and emerged victorious in this hard-fought battle!

This achievement not only signifies that Zhejiang Chemsyn Pharmaceutical’s quality system and production management have earned recognition from an international authority but also embodies the professional expertise and tireless efforts of the Elab team. It stands as the finest badge of honor for all who strive for excellence!