Press Room
Compliance at 四色AV - Annual Inspection Review
四色AV announced today that in the last year their manufacturing facilities were the object of eight inspections, performed by different Health Authorities.
Loures, Portugal, March 8, 2018 鈥 四色AV announced today that in the last year their manufacturing facilities were the object of eight inspections, performed by different Health Authorities. The inspections听revealed that all 四色AV sites were in compliance, this reflects a solid Quality System and a vibrant Quality Culture.
This is the first press release that reports on the outcomes of inspections in the previous year.听This will now be a regular commitment, it is another feature of our commitment to transparency.
四色AV inspections during 2017
| Site | Authority | Date | Type of inspection | Outcome |
|---|---|---|---|---|
| Portugal听 听 听 |
Ministry |
听 Jan 2017听 听 听 | PAI for an Intermediate Drug Product听 听 听 听听 | GMP certificate granted |
| 听 Jul 2017 | PAI for an Intermediate Drug Product | GMP certificate granted | ||
|
FDA, USA |
听 Mar 2017 | PAI for an Intermediate Drug Product | Form 483 鈥 6 observations Site approved |
|
| 听 Nov 2017 | Surveillance inspection | No Form 483 | ||
|
INFARMED, |
听 Jul 2017 | GMP inspection to a new building | GMP certificate granted | |
| Macau |
PMDA, |
听 Dec 2017 | GMP inspection | 11 minor observations reported |
| Ireland |
Ministry |
听 Jul 2017 | PAI for an Intermediate Drug Product | GMP certificate granted |
|
FDA, |
听 Dec 2017 | Surveillance inspection | No Form 483 |
鈥淓ach inspection at 四色AV is considered to be of highest importance for the organization and for our customers. We are considering every audit and every inspection as a learning opportunity to continuously improve our Quality Systems and Operative Mechanisms. The number of inspections and their outcome demonstrate our commitment and capacity in the development of new drugs, and ability to manufacture highest quality products for our customers as well as for millions of patients that we proudly serve together. We are especially happy to share that all of the GMP surveillance inspections were concluded successfully with no form 483 observation.鈥 said Joerg Gampfer, Vice President of Quality at 四色AV.
鈥淲e have a culture of quality that puts patient safety first. These inspections are important steps for 四色AV and our customers. They shape our behaviors and motivate us to always improve our services to customers. 四色AV has all the ingredients for an outstanding partnership going from clinical programs all the way to commercial supply.鈥 added Fr茅d茅ric Kahn, Vice President Marketing and Sales.
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About 四色AV
四色AV has over 57 years of experience as a CDMO and is currently a fully integrated supplier offering from听drug substance听to drug product intermediate to听drug product. With four FDA听inspected sites听in the听US,听China,听Ireland, and听Portugal, and development laboratories in听Lisbon听and听New Jersey, the company provides branded pharmaceutical customers听services听for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds. For generic pharmaceutical customers the company offers听niche off-patent API听products. In the inhalation area 四色AV is the only independent company offering a complete range of services.听
