OUR CLIENT
Pong Chien Trading Inc is an international food products importer, wholesaler, and distributor based out of Brooklyn, NY, specializing in canned goods and rice.
CHALLENGE
Complex FDA regulations and looming penalties as Pong Chien struggles to communicate with suppliers
In May 2019, food importer Pong Chien faced potential FDA penalties for not having Foreign Supplier Verification Programs (FSVPs) in place. Complex FSVP regulations combined with overseas supplier time and language barriers had left them without the proper documentation. An unexpected FDA inspection on the horizon, the company needed to prepare quickly.
Cha Jen, Pong Chien’s one-person compliance team, knew the company’s limited FSVP knowledge and experience would make it difficult to manage compliance alone. With time running out and in urgent need of a solution, the company came straight to Registrar Corp based on a vendor recommendation.
SOLUTION
Registrar Corp’s FSVP services and software helped take compliance off Pong Chien’s plate
For nearly 5 years, Registrar Corp has worked closely with Pong Chien to gain and maintain FSVP compliance. With one-on-one attention from a food safety regulatory specialist and compliance-focused software, Registrar Corp has become an extension of Pong Chien’s compliance team.
Registrar Corp has helped Pong Chien:
- Develop and implement multiple FSVPs. Pong Chien needed a total of 5 FSVPs during the five-year partnership, two of which are still active. Their dedicated regulatory specialist worked closely with the team to create and implement each plan.
- Prepare for upcoming FDA inspections. The company has had annual FDA inspections since 2019. Registrar Corp helped them maintain compliance by responding to the 483, developing and implementing new FSVP plans, and communicating with FDA as Pong Chien’s Qualified Individual about FSVP compliance as needed.
- Manage overseas suppliers. By coordinating with their Asian office to gather FSVP paperwork from Pong Chien’s Chinese suppliers, Registrar Corp’s consultative approach made the process simple.
- Manage supplier compliance. Registrar Corp’s FSVP compliance software gave Pong Chien the tools to track supplier compliance and data.
TESTIMONIAL
“My experience with Registrar Corp since we signed up has been excellent. Our dedicated regulatory specialist helped me with every inspection issue and gave advice on how to handle every situation that comes up.
She also educated me personally regarding FSVP and FDA and got the overseas department to contact our vendors for proper documentation. Our specialist has always gotten the job done and I am personally grateful she has been there for Pong Chien.“
Cha Jen, Quality Assurance Manager
IMPACT
SATISFIED SERVICE
5
Years of positive partnership with Registrar Corp
TIME SAVED
25+
Fewer hours spent annually in communication with FDA inspector and overseas department
SUCCESSFUL INSPECTIONS
4
FDA inspections passed with regulatory specialist assistance
We focus on compliance
You focus on business