Regulatory Inspections & Certifications

2019 Regulatory Inspections & Certifications

February 07, 2019 2019: Successful FDA Inspections & Certifications for CordenPharma in 2019.

October 25, 2019

CordenPharma Caponago Completes Successful Pre Approval FDA Inspection


CordenPharma is pleased to announce that on Friday, October 25th, 2019 the CordenPharma Caponago (IT) Injectable Drug Product manufacturing facility completed a seven day Pre Approval Inspection conducted by the USFDA. The new Aseptic Fill & Finish vial line facilities and the Quality Systems received a “No Action Indicated” (NAI) status after the close out of the audit: no 483s were issued.

Fabrizio Fiordigiglio, Managing Director of CordenPharma Caponago comments, “We are pleased with the outcome of the inspection. This result represents another important milestone in our ongoing strategy into the Aseptic Fill & Finish arena, and proves the robustness of our Quality system and full commitment to cGMP regulatory compliance.”

 

October 15, 2019

CordenPharma Chenôve Completes Successful FDA Inspection


CordenPharma is pleased to announce that on Friday, September 13, 2019 the CordenPharma Chenôve (FR) manufacturing facility completed a five day Inspection conducted by the USFDA. All manufacturing facilities and Quality Systems for the US were evaluated and the site has received a “Voluntary Action Indicated” or “VAI” status after the close out of the audit.

Yves Michon, Managing Director of CordenPharma Chenôve comments, “We are pleased with the outcome of the inspection. This result represents an important milestone in our ongoing commitment to continuously improving our cGMP regulatory compliance program. There is clearly work to be done to improve our systems and the whole team is looking forward to the challenge.”

 

October 1, 2019

AIFA Approves New Oncological Sterile Suite in CordenPharma Latina


CordenPharma Latina* is pleased to announce that on September 6, 2019, AIFA approved their New Oncological Sterile suite as part of the GMP renewal following the inspection which occurred in April 2019. This expansion guarantees additional capacity available for aseptic liquid and lyophilized vials. The line is equipped with the following:
• Portable dissolution vessels
• IMA Xtrema filling and stoppering with Restricted Access Barrier System (RABS)
• IMA LYOFAST 25 Freeze Dryer (27.9m2, 15 shelves)
• Opportunity to install a second Freeze Dryer

This investment is part of an extensive project and consistent with CordenPharma Latina’s long term strategy.

*Corden Pharma Latina S.p.A. was acquired by a Third Party (not affiliated to CordenPharma)

 

September 27, 2019

CordenPharma Latina Completes Successful FDA Inspection


CordenPharma is pleased to announce that on Friday September 27th, the CordenPharma Latina* (Italy) manufacturing facility completed a 10 day Inspection conducted by the USFDA. All facilities and Quality Systems manufacturing for the US (both APIs & Drug Products) were evaluated. The site received 3 FDA 483 observations, which represents a significant improvement over previous inspections.

Alessandro Zucconi, Managing Director of CordenPharma Latina comments, “We are tremendously proud of this outcome. I want to thank the entire CordenPharma Latina team for their diligence, rigor and enthusiasm. This result is another important milestone for our future, as we are fully committed to continuously improving our cGMP regulatory compliance program.”

*Corden Pharma Latina S.p.A. was acquired by a Third Party (not affiliated to CordenPharma)

 

July 23, 2019

CordenPharma Plankstadt Awarded Corporate Social Responsibility Silver Medal by EcoVadis


CordenPharma Plankstadt (DE) are pleased to announce the award of the Silver medal by the independent agency EcoVadis in June 2019 as a recognition of their CSR (Corporate Social Responsibility) Rating. The rating is a testament to CordenPharma’s dedication to sustainability with regards to environmental, labor & human rights, ethics and sustainable procurement. CordenPharma received an overall score of 87th percentile.

Dr. Riku Rautsola, CEO of CordenPharma & Acting Managing Director of CordenPharma Plankstadt commented, “We are excited to receive The EcoVadis silver rating for our initiatives in Plankstadt, as Corporate Social Responsibility plays an important role in the strategy of our growing business. As a CDMO, we are consistently seeking ways to make a positive impact on social, economic & environmental factors which affect our employees, their communities and the world at large.”


February 7, 2019

CordenPharma Colorado Completes Successful FDA Inspection


CordenPharma is pleased to announce that on February 6, 2019 our CordenPharma Colorado (USA) manufacturing facility completed a 6 day surveillance Inspection conducted by the US FDA. All Quality Systems were evaluated. The facility received a successful response with one FDA 483 observation reported.

Brian McCudden, Managing Director of CordenPharma Colorado comments, “We are pleased with the outcome of the FDA Inspection, as it reflects our high level of compliance with cGMP regulations & guidelines and the commitment, talent and professionalism of our staff.”