Navigation Links
AMRI receives FDA notification on proposed corrective actions

Albany, NY (September 26, 2011) - AMRI (NASDAQ: AMRI) today announced the receipt of a letter from U.S. Food and Drug Administration (FDA) regarding its Burlington, Massachusetts aseptic finish-and-fill facility, acquired in June 2010. The letter pertained to AMRI's written responses to a August 2010 warning letter and a June 2011 Form 483, and stated that corrective actions proposed by AMRI, once fully implemented, should adequately address the observations made by the FDA investigators.

The Company is on track to fully implement all corrective actions related to the 2011 Form 483 within October of this year and intends to present a written report on the remaining open items to the FDA following completion of these activities. According to the FDA letter, AMRI's corrective actions will be verified by the FDA at the next facility inspection. AMRI has resumed and is continuing manufacturing operations at the Burlington site, including GMP fills for customer projects.

"We are encouraged that the FDA believes the corrective actions we have made and are implementing should adequately address the observations raised from recent inspections," said AMRI's Chairman, President and CEO, Thomas E. D'Ambra, Ph.D. "This is an important, positive step in resolving the issues raised by the FDA with respect to our Burlington, MA facility. Although we believe the actions described in our submissions address the FDA observations, we are continuing to take additional actions to improve our quality, culture and performance at our Burlington operations. We are actively taking steps to rebuild Burlington's book of business. AMRI remains committed to ensuring the quality and safety of our products and processes at all of our locations."


Contact: Yolanda Meleco

Page: 1

Related medicine news :

1. Brigham and Womens Hospital researcher receives NIH Transformative Research Project Award
2. First US patient receives specially processed donor lungs at the University of Maryland
3. University of Kentucky Sanders-Brown Center on Aging receives $7 million from NIA
4. AMRI receives NIH contract award for development of pre-clinical drug candidates
5. Mayo Clinic receives FDA approval for ovarian and breast cancer vaccines
6. Dale Browne, M.D., ear, nose, and throat specialist, receives award from National Medical Society
7. John House, MD, ear, nose, and throat specialist, receives award from National Medical Society
8. Wayne State researcher receives NSF award to develop neural implants
9. Dr. Joanne Jordan receives Distinguished Service to Rural Life Award
10. Hutchinson Center receives $8.2M to coordinate obesity and cancer consortium
11. Harvard School of Public Health receives $14.1 million to test childbirth checklist
Post Your Comments:
(Date:11/25/2015)... Ill. (PRWEB) , ... November 25, 2015 , ... ... and potentially more aggressive than those found on mammography, according to a study ... findings of additional cancers not seen on mammography may necessitate a change in ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... factory direct sauna parts and accessories. , Sauna accessories help improve the bather ... style and personality. From basic styles for the purist looking for simplicity in ...
(Date:11/25/2015)... , ... November 25, 2015 , ... According to an ... robot is being more and more widely heralded as a breakthrough for performing hernia ... method has over traditional laparoscopic surgery is that it can greatly reduce the pain ...
(Date:11/25/2015)... , ... November 25, 2015 , ... The McHenry County ... recent successful appellate decision obtained by Attorneys Francisco J. Botto and Alex C. Wimmer. ... Illinois Workers’ Compensation Comm’n, 2015 IL App (2d) 130884WC. , According to court documents, ...
(Date:11/25/2015)... ... 25, 2015 , ... Brillianteen, McGaw YMCA’s student-produced musical show, ... 65th Anniversary Brillianteen Revue, scheduled for March 4-6, 2016. Auditions for this final ... has been a treasured tradition for numerous families in the Evanston community. Over ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... Allergan plc (NYSE: AGN ), ... a start-up  biotechnology company focused on the development ... funded by the F-Prime Biomedical Research Initiative (FBRI), ... exclusive collaboration to support the discovery and development ... and Obsessive Compulsive disorders (OCD). ...
(Date:11/25/2015)... Ohio , Nov. 25, 2015 ... handle hazardous drug preparations (e.g. pharmacists, pharmacy technicians, ... and veterinary technicians). The chapter also covers all ... drugs (e.g., pharmacies, hospitals, other healthcare institutions, patient ... --> --> ...
(Date:11/25/2015)... 2015 Asia -based ... BioLight and the New Investors will make a direct ... a private placement. The financing will help IOPtima to ... used in the treatment of glaucoma, as well as ... IOPtimate™ system with the U.S. Food and Drug Administration, ...
Breaking Medicine Technology: