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World Leading Manufacturing Company in Malaysia Attains USA FDA Facility Registration

World Leading Manufacturing Company in Malaysia Attains USA FDA Facility Registration

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IoT For All

- Publish Date: August 18, 2021

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IoT For All

- Publish Date: August 18, 2021

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Ge-Shen, a B2B leader in design, technology, and development of manufactured products for clients globally, has announced today that it now has FDA Registered facilities, in an ever-growing effort to continue to deliver safe and responsible manufactured products, inside the medical and food trades, 100% of the time.

The FDA is perhaps the best-known regulatory body of its kind, responsible for ensuring the safety of medicines, medical devices, and food. When it comes to these critical products, the FDA is synonymous with quality and trust. The FDA requires all imports of these products to be well documented and accountable so that any issues can be traced back. Registration and listing provide the FDA with the locations of medical device establishments and the devices manufactured at those establishments.

In a recent FDA report, it is noted that there were only 552 FDA registered facilities in Malaysia at the beginning of the year 2021. Ge-Shen today joins the small but growing number of FDA registered facilities in the nation, as the corporation continues to revamp its efforts to better cater to its emergent client base in the USA.

Louis Lau, Executive Director of Ge-Shen Corporation, comments: “We are immensely proud today to have FDA registered manufacturing facilities. Our corporation is deeply committed to the regulatory requirements that make a product great and safe for consumers. We know how to ensure that your medical or food grade products are manufactured and delivered without any worry – attaining this FDA registration is yet another step towards continuously showing our clients that they can trust our decades of industry expertise.

“Ge-Shen is equipped with FDA registered facilities and ISO 13485 quality systems, so that we can ensure confidence, trust and accountability for products manufactured by us.”

Recently, Ge-Shen doubled down its efforts to meet future manufacturing demands in the medical, food and household sector across the USA by investing $1.5 million USD towards another certified 100K cleanroom.

Today, US based clients encompass over 30% of Ge-Shen’s business

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About Ge-Shen

Founded in 1995, Ge-Shen celebrates its 25th year as a precision injection moulding contract manufacturer this year. Ge-Shen has great experience in high-precision, injection moulding for audio products with great emphasis on aesthetics. In recent years, the company started diversifying into different industries with a focus on the medical, life sciences, food, home and lifestyle product sectors. To meet client demand, Ge-Shen has made large investments in upgrading its facilities. Ge-Shen has ISO 9001 and ISO 13485 certified locations across Malaysia and Vietnam. The company specializes in top-of-the-line products at competitive prices.

For more information, please contact Louis Lau, Executive Director of Ge-Shen Corporation at [email protected]

 

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LinkedIn: https://www.linkedin.com/company/ge-shen-corporation-berhad/

Facebook: GeShenCorp

 

Media Relations and Corporate Affairs

Alicia Orta Stanford

[email protected]

 

 

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