Regulatory Inspections & Certifications
November 26, 2018
CordenPharma is pleased to announce that our CordenPharma Bergamo (IT) Active Pharmaceutical Ingredient (API) manufacturing facility, completed a four day general inspection conducted by the U.S. Food and Drug Administration (FDA) in September 2018. The inspection outcome has now been closed (November 16th) by the FDA and classified with a “VAI” status (Voluntary Action Indicated).
Esua Macniell, Chief Compliance Officer of CordenPharma Group comments, “We are pleased with the outcome and the rapid closure of the FDA Inspection at CordenPharma Bergamo. This is the fourth successful inspection of a CordenPharma manufacturing site in 2018 and reflects our high level of professionalism, authenticity and cGMP regulatory compliance, which fully lives up to the laws and regulations of the United States Authorities.”
November 19, 2018
CordenPharma Colorado has successfully completed the Potent Compound Recertification Audit by SafeBridge® Consultants. Certification has been maintained since first awarded in 2013.
The onsite assessment included the evaluation of physical plant features, programs, exposure controls, procedures and practices applied towards the manufacturing of highly potent Active Pharmaceutical Ingredients (APIs), consisting of a review of over 60 elements.
By meeting the criteria established under the SafeBridge® program, CordenPharma Colorado is deemed competent and proficient in the safe handling of potent APIs and compounds.
“Containment of highly potent compounds is a multi-faceted endeavor that goes far beyond the installation of good containment equipment. The strength of our containment program is demonstrated by our approach from all directions, including engineering controls, a containment culture, process development, occupational health pre-planning, and an ongoing containment execution cycle,” comments Robin Livingston, Manager, Environmental and Health & Safety, CordenPharma Colorado.
“CordenPharma Colorado has a long and successful history in manufacturing highly potent APIs, with robust processes in place to handle compounds well below 50 ng/m3 OEL. SafeBridge’s recertification provides objective and scientifically supported assessment further validating our capabilities to support customers with any challenge they bring our way,” says Jason Bertola, Director, Global Highly Potent & Oncology Platform, CordenPharma International.
November 2, 2018
CordenPharma is pleased to announce that on November 2, 2018 the US Food and Drug Administration (FDA) completed a 5-day inspection of our CordenPharma Switzerland manufacturing facility. The inspection focused on product-specific processes and documentation in the cGMP compliant production of APIs and various multi-customer phospholipids used as excipients, as well as a general review of our site-wide quality system.
The facility received a successful response with no FDA Form 483 observations reported. The inspector expressly praised the open, supportive and positive behavior of the audited employees, along with their high level of professionalism and competence. It was also acknowledged that a tremendous amount of high-quality preparatory work was done.
Juerg Burger, Managing Director of CordenPharma Switzerland comments, “We are proud with the outstanding result of the recent FDA inspection, which directly reflects the tireless individual commitment of every single employee in their daily work at CordenPharma Switzerland.”
July 18, 2018
CordenPharma is pleased to announce that in July 2018 our CordenPharma Caponago (IT) injectable manufacturing facility completed a wide Pre-Approval Inspection (PAI) conducted by the US FDA. The facility received an FDA 483 form, which was limited to a few minor observations. Accordingly, the FDA inspector proposed a Voluntary Action Indicated (VAI) status that would suggest approval for all the involved products addressed in the PAI, two of which are going to be manufactured in the new Aseptic Fill & Finish Line in CordenPharma Caponago.
Fabrizio Fiordigiglio, Managing Director of CordenPharma Caponago comments, “We are pleased with the outcome of the FDA PAI Inspection in July 2018 as it reflects our high level of professionalism and attention to cGMP regulatory compliance in all production and quality processes according to the laws and regulations of the United States Authorities.”
July 09, 2018
CordenPharma is pleased to announce that in July 2018 our CordenPharma Plankstadt (DE) manufacturing facility completed a general inspection conducted by the US FDA. The facility received a successful response with no FDA 483 observations reported.
Frank Haehner, Managing Director of CordenPharma Plankstadt comments, “We are pleased with the outcome of the FDA Inspection in July 2018 as it reflects our high level of professionalism, authenticity and cGMP regulatory compliance, which fully lives up to the laws and regulations of the United States Authorities.”
April 04, 2018
CordenPharma is pleased to announce that in March 2018 our CordenPharma Boulder (CO, USA) manufacturing facility completed a general Inspection conducted by the US FDA. All Quality Systems were evaluated. The facility received a successful response with no FDA 483 observations reported.
Brian McCudden, Managing Director of CordenPharma Boulder comments, “We are pleased with the outcome of the FDA Inspection in March 2018, as it reflects our willingness to comply with the highest level of cGMP regulatory compliance and represents an important milestone for our CordenPharma Boulder facility, following its acquisition from Pfizer in November of 2017.”