CordenPharma enhances quality, compliance systems following FDA warning

By Melissa Fassbender contact

- Last updated on GMT

CordenPharma Latina's US FDA warning letter has closed. (Image: iStock/utah778)
CordenPharma Latina's US FDA warning letter has closed. (Image: iStock/utah778)
CordenPharma has implemented work to improve its quality and compliance systems after its Latina facility was issued a warning letter from the US FDA in May of last year.

CordenPharma International’s Latina facility received the warning letter​ from the US Food and Drug Administration (FDA) on May 20, 2016.

The letter was issued following a May 2015 inspection of the Sermoneta, Italy-based facility, which manufactures oral and sterile anti-infective penicillins and cephalosporins.

Today, the contract development and manufacturing organization (CDMO) has announced that the warning letter has been closed as of August 15, 2017.

This success is the result of a holistic and systematic approach to remediate the observations throughout the facility​,” the company said in a release.

Following the inspection, CordenPharma’s Corporate Compliance Team developed an approach to enhance its quality and compliance systems. According to the company, this included a systematic review and assessment of all its facilities.

Moving forward, it has planned a “long-term high investment​” program that will address corporate and quality systems, organizational structure and infrastructure, and includes a process to involve customers in improving transparency.

Related news

Related products

VDS groß

Meet the challenges of complex injectables

Vetter Pharma International GmbH | 07-Nov-2017 | Technical / White Paper

In the time it takes from the exciting discovery phase to the rigorous demands of a commercial launch, unexpected scientific and technical challenges can...

lyo_vials

Process Development for Lyophilized Products

Baxter BioPharma Solutions | 30-Oct-2017 | Application Note

Baxter approaches formulation and process development with the intention of identifying the failure points for the product. Knowing where the product fails...

Related suppliers